araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Non Invasive Detection of IDH1/2 Mutation in Gliomas

Summary: This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.
  In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.
  In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.

Detailed description: The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
  The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
  The secondary endpoints include:
  1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
  2. Differentiation of tumor recurrence from radiation induced changes
  3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction

Eligibility: Inclusion criteria
  1. Affiliation to a social security system
  2. Patient≥ 18 years old
  3. Written informed consent
  4. One of the two situations:
  -  presumed grade II-III glioma candidate to surgery (group 1)
  -  IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
  5. Evaluable tumoral mass min diameter >2 cm (FLAIR)
  6. PKPS > 60
  Exclusion criteria
  1. Contra-indication to MRI
  2. Patient unable to give an written Informed Consent
  3. Patient under guardianship or deprived of freedom
  4. For group 2: patient already included in group 1

Relevance to patient case: possibly relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Determination of Immune Phenotype in Glioblastoma Patients

Summary: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.


Eligibility: Inclusion Criteria:
  -  adult glioblastoma multiforme
  Exclusion Criteria:
  -  pregnancy, unable to give consent

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Summary: The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).


Eligibility: Inclusion Criteria:
  -- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.
  -  Documentation of IDH1R132 mutation of tumor
  -  ECOG performance status ≤ 2
  -  Clinically fit for standard of care medication per protocol.
  Exclusion Criteria:
  -  Prior treatment for AML or MDS
  -  Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
  -  Acute Promyelocytic Leukemia
  -  Women who are pregnant or lactating
  Other protocol-defined Inclusion/Exclusion may apply

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Glioblastoma Platelet Activation Study

Summary: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
  Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Detailed description: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
  Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Eligibility: Inclusion Criteria:
  -  MR-morphological suspicion for glioblastoma
  -  informed consent
  Exclusion Criteria:
  -  no informed consent

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: uPAR-PET/MRI in Glioblastoma Multiforme

Summary: The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

Detailed description: 68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Eligibility: Inclusion Criteria:
  -  Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery
  -  The participants must be capable of understanding and giving full informed written consent
  -  age above 18 years
  Exclusion Criteria:
  -  Pregnancy
  -  Lactation/breast feeding
  -  Age above 85 years old
  -  Weight above 140 kg
  -  Known allergy towards 68Ga-NOTA-AE105

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Comparative Study of the TOMEY Specular Microscope EM-4000 and the Konan CellChek XL

Summary: The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.

Detailed description: The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium by capturing an image of corneal endothelium tissues. without making contact, analyzing the captured image, and calculating data such as cell density.

Eligibility: Inclusion Criteria－Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
  1. Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  3. Subjects who agree to participate in the study.
  Inclusion Criteria －Pathologic adults (29-80 years old):
  1. Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  3. Subjects who agree to participate in the study;
  4. At least one eye with any of the following conditions:
  1. History of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy
  2. History of corneal transplant
  3. Physical injury or trauma to the cornea
  4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
  5. Keratoconus
  6. Long-term polymethyl methacrylate (PMMA) contact lens use (greater than 3 years).
  Exclusion Criteria - Non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old)
  1. History of post-op surgical trauma including bullous keratopathy;
  2. History of corneal transplant;
  3. Evidence of physical injury or trauma to the cornea;
  4. Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
  5. Keratoconus;
  6. Long-term PMMA contact lens use (greater than 3 years);
  7. History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
  8. Fixation problems which may prevent obtaining good Tomey EM-4000 and Konan CellChek XL images in either eye.
  Exclusion Criteria - Pathologic adults (29-80 years old)
  1. History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
  2. Fixation problems which may prevent obtaining at least poor quality Tomey EM-4000 and Konan CellChek XL images in either eye.

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Efficacy and Safety of IDP-124 Lotion

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: Key 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
  Key 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)

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

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: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

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: possibly relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

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: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

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
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: CAN008 Biomarker CD95 Ligand and CpG2 Methylation in Chinese Patients With Glioblastoma

Summary: This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices are necessary for all the CD95 and CpG2 test in the central lab by the methods of immunisation and DNA methylation.


Eligibility: Inclusion Criteria:
  -  Chinese nationality
  -  No limits on Gender and age
  -  First diagnosed GBM
  -  Brain tumor tissue cytological diagnosis of glioblastoma (GBM, pleomorphic glioblastoma, WHO level IV)
  Exclusion Criteria:
  -  Other types of glioma by histological diagnosis
  -  Tumor tissue not eligible for the central laboratory testing standard
  -  No enough tumor tissue for the central laboratory test

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

Summary: This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Adequate hematologic and organ function
  Exclusion Criteria:
  -  Active or history of medically significant autoimmune disease
  -  Cytotoxic therapy or investigational agent use within 28 days
  -  Human immunodeficiency virus (HIV), active hepatitis B or C
  -  Untreated brain metastases
  -  Known QT interval prolongation
  -  Use of concomitant medications with high risk of causing Torsades des Pointes.
  -  Use of immune suppressive agents within 30 days
  -  More than one active malignancy at the time of enrollment

Relevance to patient case: not relevant