araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

Summary: This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
  Gefitinib 250 mg will be administered orally daily.
  To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with Gefitinib
  8. Patients with a risk factor of interstitial lung disease

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

Summary: KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).
  Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.


Eligibility: Inclusion Criteria:
  1. age ≥ 20
  2. advanced, refractory cancer patients who failed standard of care (SOC)
  3. KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
  4. ECOG performance status of 0~2
  5. measurable or evaluable lesion per RECIST 1.1 criteria
  6. adequate marrow, hepatic, renal and cardiac functions
  -  Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
  -  Total serum bilirubin ≤ 1.5 x ULN
  -  Absolute neutrophil count(ANC) ≥ 1,500/uL
  -  Platelets ≥ 100,0000/uL
  -  Hemoglobin ≥ 9.0 g/dL
  7. provision of a signed written informed consent
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. history of major surgery or radiotherapy within 4 weeks
  4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
  5. known history of hypersensitivity to study drugs

Relevance to patient case: possibly relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

Summary: The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.
  In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.


Eligibility: Inclusion Criteria:
  Outcome Measure #1 and #2
  -  Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
  -  Participants must be 18 years or older
  -  Participants must be able to understand and willing to sign a written informed consent document
  Outcome Measures #3 and #4
  -  Patients with either cutaneous, visceral or brain melanoma metastases.
  -  Participants must be 18 years or older.
  -  Participants must be Eastern Cooperative Oncology Group (ECOG) status 0-3.
  -  Participants must be able to understand and willing to sign a written informed consent document.
  Exclusion Criteria:
  -  Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
  -  ECOG status > 3

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Walking Meditation Exercise in Breast Cancer Patients

Summary: This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy

Detailed description: Walking Meditation program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking while listening to the sound "Budd" and "Dha" and squeeze rubber balls according to the sound in order to practice mindfulness while walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between set. In both phases of the training, the frequency of Walking Meditation training is three times a week.

Eligibility: Inclusion Criteria:
  1. The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive.
  2. All participants will be planned to use Anthracyclines chemotherapy in next 1 month by oncologist.
  3. All participants did not participate in any exercise training in the past 6 months
  4. All participants are free from acute or chronic renal failure, Heart Failure, Myasthenia gravis, pregnancy and history of smoke.
  Exclusion Criteria:
  1. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme

Summary: The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.

Detailed description: The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).

Eligibility: Inclusion Criteria:
  -  Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder
  Exclusion Criteria:
  -  Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Etiology of Endocarditis in Negative Blood Cultures

Summary: Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral diseases, should increase the number of positive etiological diagnosis of culture-negative samples.
  Secondly, because of the seriousness of the disease, the investigators were led to develop a new score: score for admission. This score, realized in less than 4 hours from the admission of the suspected patient with endocarditis, should allow for immediate probabilistic antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated and, where appropriate, empirical antibiotic therapy started.
  Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of endocarditis.
  Secondary: Validate the "admission" score compared to the modified Duke score.


Eligibility: Inclusion Criteria:
  -  Patient with endocarditis diagnostic kit prescribed
  -  Patient is more than 18 years old
  -  Patient who freely signed written informed consent.
  -  Patient affiliated to a health assurance
  Exclusion Criteria:
  -  Minor patient (<18 years)
  -  Patient pregnant or breastfeeding
  -  Patient incapable or unable to consent
  -  Private patient of liberty or under court order
  -  Patient refusing to participate in the research

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Summary: Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
  In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

Detailed description: The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
  The secondary objectives of this study will be:
  -  Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  -  Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Eligibility: Inclusion Criteria:
  -  patient with melanoma confirmed histologically
  -  patient with metastatic melanoma (stage III unresectable or stage IV)
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  - Metastatic tumor whose origin is doubtful (uncertain melanoma)

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection

Summary: Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in patients undergoing uterine cancer resection.


Eligibility: Inclusion Criteria:
  -  patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  -  patient scheduled for uterine cancer surgery
  Exclusion Criteria:
  -  ASA physical status Ⅳ
  -  severe hepatorenal disease
  -  infection
  -  metastasis to other organ
  -  problem with communication

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Summary: The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility: Inclusion Criteria:
  -  Subjects currently working at the Local Health Authority of the province of Bergamo
  Exclusion Criteria:
  -  Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

Summary: The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
  -  Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
  -  Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  -  Life expectancy ≥ 3 months
  -  Adequate organ and bone marrow function
  -  Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
  -  Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
  -  Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
  Exclusion Criteria:
  -  Prior treatment with a KIT inhibitor for melanoma
  -  Presence of NRAS or BRAF mutation
  -  Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
  -  Symptomatic brain metastases.
  -  Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
  -  Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
  -  Uncontrolled intercurrent or infectious illness
  -  Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
  -  Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
  -  Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
  -  Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is permitted); or serious cardiac arrhythmia
  -  Baseline QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  -  Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  -  Known chronic liver disease
  -  Women who are breast-feeding or pregnant

Relevance to patient case: possibly relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

Summary: This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Detailed description: After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Eligibility: Inclusion Criteria:
  -  Biopsy proven T2 malignant melanoma.
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-2.
  Exclusion Criteria:
  -  Visible additional disease that suggests a greater than T2 malignant melanoma
  -  Unable to tolerate general anesthesia
  -  Evidence of distant metastatic disease
  -  Melanoma located on face or digits

Relevance to patient case: not relevant
Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma

Summary: The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because of the heterogeneity of tumor. It is also not applicable for patients who are not suitable for surgical procedure due to the tumor location or patients' general conditions. Because of the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis, maintenance, and progression of high grade glioma, there has been an intense effort to develop noninvasive molecular imaging approach for the selection and monitoring of EGFR-targeted therapies.
  Based on investigators' previous study, investigators plan to perform PET scanning on the participants with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, investigators precisely obtain the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.


Eligibility: Inclusion Criteria:
  1. Clinical manifestations and imaging examination (CT, MRI, et al) are in accordance with high grade glioma
  2. No PET/CT scanning contraindications
  3. No MRI scanning contraindications
  4. Patients older than 18 years old
  5. ECOG score between 0 to 2
  6. Patients with sufficient bone marrow, kidney and liver function reserve.
  7. All patients gave written informed consent.
  Exclusion Criteria:
  1. Patient who has received immune therapy, radiation therapy, chemotherapy, hormone drugs, biological products or other clinical trials within 14 days.
  2. Patient who has received EGFR monoclonal antibody therapy within 4 weeks.
  3. Patients who has not fully recovered form the past drug toxicity reaction (CTCAE in grade 2 or above).
  4. Patient who has received major surgery within 7 days.
  5. Patients with allergies to immunoglobulin.
  6. Breastfeeding women.
  7. pregnant women
  8. Patients with severe clinical condition.
  9. Inability to give informed consent

Relevance to patient case: not relevant