araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

Summary: Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Detailed description: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Eligibility: Key Inclusion Criteria:
  -  Male or female at least 12 years of age and older.
  -  Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
  -  Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
  -  Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.
  Key Exclusion Criteria:
  -  Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
  -  Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema.
  -  Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
  -  Subjects with a facial beard or mustache that could interfere with the study assessments.
  -  Evidence or history of cosmetic-related acne.
  -  Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Summary: Synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.

Detailed description: Phase II multi-cohort study based on two-stage Simon design. The primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) or specific criteria for prostate cancer.

Eligibility: Inclusion Criteria:
  -  Histologically proven advanced solid tumor patients (recurrent or metastatic), not amenable to curative therapy. Patients must have progressed to standard treatment proven to prolong survival or no standard treatment exists. Tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, breast cancer, cervix cancer, prostate cancer, melanoma, pancreas adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma
  -  No concurrent active systemic treatment
  -  Measurable disease by RECIST v1.1
  -  Clinical or radiological progression in the last three months
  -  Eastern Cooperative Oncology Group Performance Status 0-1
  -  Ability to consent
  -  Adequate organ function
  -  Life expectancy greater than 12 weeks
  -  Ability to swallow
  -  No previous malignancy in the last 5 years
  Exclusion Criteria:
  -  Pregnancy
  -  Corticosteroid therapy for prostate cancer
  -  Uncontrolled comorbidity
  -  Known hepatitis B, C and HIV
  -  Central nervous system involvement, except if controlled symptoms and without corticosteroids
  -  Previous use of phosphoethalonamine

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Summary: This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.
  This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Detailed description: The study will be conducted as follows:
  1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
  2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Eligibility: Inclusion criteria:
  -  Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);
  -  AML patients;
  -  Age ≥18;
  -  IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
  Exclusion criteria:
  -  AML M3 subtype according to the FAB classification;

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Low Grade Chondrosarcoma Versus Enchondroma

Summary: The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).

Detailed description: The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.

Eligibility: Inclusion Criteria:
  -  chondroma or low grade chondrosarcoma of long bones
  Exclusion Criteria:
  -  chondroma or low grade chondrosarcoma of spine and pelvis

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Summary: Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Detailed description: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Eligibility: Key Inclusion Criteria:
  -  Male or female at least 9 years of age and older;
  -  Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
  -  Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
  -  Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
  -  If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.
  Key Exclusion Criteria:
  -  Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
  -  Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
  -  Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
  -  Subjects with a facial beard or mustache that could interfere with the study assessments.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Summary: The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
  2. Progressive disease who failed to previous standard treatment.
  3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
  4. Eastern Cooperative Oncology Group performance status 0 or 1
  5. Able to take medications orally
  6. Adequate organ function
  7. A life expectancy of at least 60 days
  Exclusion Criteria:
  1. Previous treatment with anti-PI3K or AKT directed therapies
  2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
  3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
  4. Current evidence of retinopathy that requires ophthalmological therapy.
  5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
  6. Treatment with any of the following within the specified time frame prior to study drug administration:
  -  Major surgery within prior 4 weeks
  -  Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
  -  Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
  7. A serious illness or medical condition(s)
  8. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
  9. Patients with the risk of hypokalemia
  10. Receiving oral steroid medication.
  11. Pregnant or lactating female

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)

Summary: The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.
  Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.


Eligibility: Inclusion Criteria:
  Written informed consent
  -  Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
  -  Histologically proven advanced and/or metastatic STS, intermediate/high grade
  -  Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
  -  Patients indicated for 1st line treatment with trabectedin according to local SmPC
  -  ECOG Performance Status 0, 1 or 2
  -  bone marrow function according to local SmPC
  -  hepatic function according to local SmPC
  -  Ability to understand and follow study-related instructions
  Exclusion Criteria:
  -  Histologically proven advanced and/or metastatic STS of the following tumor types:
  -  Embryonal rhabdomyosarcoma
  -  Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
  -  Osteosarcoma (excluding extraskeletal osteosarcoma)
  -  Ewing tumors/primitive neuroectodermal tumor
  -  Gastrointestinal stromal tumors
  -  Dermatofibrosarcoma protuberans
  -  Use of any investigational agent within 28 days prior to treatment start
  -  Exclusion periods from other studies or simultaneous participation in other clinical studies
  -  Contraindications according to the local SmPC of Yondelis® (see Appendix A)
  -  Subject is in custody by order of an authority or a court of law
  -  Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
  -  Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

Summary: This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.


Eligibility: Inclusion Criteria:
  1. Has histologically confirmed glioma with an IDH1-R132 mutation
  2. Has disease that has recurred or progressed following standard treatment including radiotherapy
  3. Has measurable lesion(s) as per RANO criteria
  4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  Exclusion Criteria:
  1. Has significant symptoms of increased intracranial pressure
  2. Has another active neoplasm
  3. Has active infection requiring systemic treatment
  4. Has a history of severe cardiac disease
  5. Has had prior treatment with any inhibitor targeting mutant IDH1
  6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
  7. Is a pregnant or lactating female

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Summary: Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Detailed description: A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Eligibility: Inclusion Criteria:
  -  Male or Female of any race, at least 18 years old of age (inclusive)
  -  Freely provides both written and oral informed consent.
  -  Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
  -  Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
  -  The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
  Key Exclusion Criteria:
  -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
  -  Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
  -  Has a history of adrenal disease.
  -  Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
  -  Is pregnant, nursing, or planning pregnancy during the study period.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Summary: Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Detailed description: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Eligibility: Inclusion Criteria:
  -  Male or female at least 2 years of age and older
  -  Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
  -  Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable
  -  Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing
  Exclusion Criteria:
  -  Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
  -  Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
  -  Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
  -  History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
  -  History or presence of:
  -  basal cell carcinoma of skin effectively treated more than 2 years ago
  -  carcinoma of cervix effectively treated more than 5 years ago
  -  immunological deficiencies or diseases, HIV, or serious recurrent infection
  -  clinically significant severe renal insufficiency or severe hepatic disorders
  -  Current or recent serious infection

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Noninvasively Predicting Gene Status of Glioma

Summary: Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. Amide proton transfer (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of isocitrate dehydrogenase (IDH) gene status in glioma.

Detailed description: Materials and Methods:
  The whole brain MRI examinations were performed on a 3.0-T MRI system (Discovery MR750, General Electric Medical System, Milwaukee, WI, USA) with an eight-channel head coil (General Electric Medical System). Conventional MRI, contrast-enhanced MRI, DWI and amide proton transferimaging were performed in regular sequence during the same examination. Finally, contrast-enhanced T1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (Omniscan; GE Healthcare, Co. Cork, Ireland).
  MRI data processing and image analysis:
  All data were transferred to a workstation (Advantage Workstation 4.6, General Electric Medical System, Milwaukee, Wisconsin, USA) for processing.The MR imaging of all the patients were assessed independently by two experienced neuroradiologist (HYC and YLF, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. Next, a region of interest (ROI) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on APT image.
  Statistical analysis:
  Categorical data obtained from image were calculated using the Fisher's exact test. Quantitative data were denoted as the mean and standard deviation. The Kolmogorov-Smirnov (K-S) test was used to assess the normality of data distribution.APT-weighted (APTw) signal intensity were tested for differences between the IDH mutation and the IDH wild-type by using independent sample t test.

Eligibility: Inclusion Criteria:
  -  no hypertension or cerebral vascular diseases
  -  no use of corticosteroid drugs
  -  no MRI contraindication
  -  no allergic constitution
  Exclusion Criteria:
  -  pregnant wowan
  -  motion cause poor image quality

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

Summary: To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)


Eligibility: Inclusion Criteria:
  -  Patients with advanced AML that harbors IDH1 mutation
  -  Patients are relapsed from or refractory to at least 1 previous line of therapy
  -  Good kidney and liver function
  -  Male or female patients
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal
  Exclusion Criteria:
  -  Previously treated with any prior mIDH1 targeted therapy
  -  Extramedullary disease only
  -  History of clinically significant or active cardiac disease
  -  Active clinically significant infection
  -  Unresolved chronic toxicity of previous AML treatment
  -  Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
  -  Pregnancy or breast-feeding

Relevance to patient case: not relevant