araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia

Summary: RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.

Detailed description: Constitution of a prospective cohort of 128 patients with 8 different groups of patients. This protocol is designed to evaluate a new tool for detecting the diversity of the repertoire T and B in patients with hematological disease. This in vitro diagnostic device is consisting of molecular biology kits Human ImmunTraCkeR® and Human Immun'IgH® and the analysis tool NDL®

Eligibility: Inclusion Criteria:
  -  18 Years and older
  -  Subjects with a diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, MALT, marginal zone, Waldenstrom's disease, chronic lymphocytic leukemia, T-cell lymphoma, anaplastic, cytotoxic or peripheral unspecified angioimmunoblastic.
  -  Have signed an informed consent for participation in the study and preservation of blood samples for biomedical research.
  -  Accept to appear in consultation biological samples at the sampling points corresponding to its group.
  -  The benefits of social security.
  Exclusion Criteria:
  -  Subjects with a diagnosis of Hodgkin disease
  -  Subjects with a diagnosis of T-prolymphocytic leukemia
  -  Subjects with a diagnosis of Burkitt's lymphoma
  -  Subjects with a diagnosis of lymphoblastic lymphoma
  -  Subjects who had prior-treatment for hematological disease
  -  Patients under judicial safeguards

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

Summary: RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

Detailed description: To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.
  To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
  -  Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent
  -  Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.
  Exclusion Criteria:
  -  Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Obvious cavity or necrosis formed in the tumor
  -  Uncontrolled hypertension
  -  Hymoptysis, more than 2.5ml daily
  -  Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
  -  Received big surgery, had bone fracture or ulcer in 4 weeks
  -  Urine protein >++, or urine protein in 24 hours> 1.0g
  -  pregnant or lactating woman
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to apatinib or any of it components.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)

Summary: To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.


Eligibility: Inclusion Criteria:
  1. Signed and dated informed consent
  2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
  3. ECOG PS:0-1,Life expectancy of more than 6 months
  4. main organs function is normal
  Exclusion Criteria:
  1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
  2. Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
  3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
  4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
  5. Patients with factors that could affect oral medication (such as dysphagia etc.)
  6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
  7. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Prospective, Multiparametric Biomarker Study to Identify Predictors of Treatment Response and Resistance in Patients With EGFR-mutated Non-small-cell Lung Cancer Receiving Maintenance Therapy With Either Afatinib or Pemetrexed With the AIO-TRK-0114 Study (MARBLE)

Summary: The aim of Trans-MARBLE is to identify and validate novel biomarkers of response and resistance to maintenance therapy with afatinib or pemetrexed in patients with EGFRmutated non-small-cell lung cancer who have progressed after first-line therapy with afatinib.

Detailed description: Patients with EGFR-mutated non-small-cell lung cancer who have progressed after first-line therapy with afatinib and participate in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36) are offered participation in Trans-MARBLE. If written informed consent is granted, archival surplus diagnostic tumor samples, blood samples and fresh tumor samples are acquired during medically indicated diagnostic procedures.
  All samples will be pseudonymized and shipped to the Coordinating Study Laboratory and Biobank (WBE) in Essen or to the Central ctDNA Sequencing Laboratory in Cologne. Biomaterials including DNA, RNA and proteins will be extracted and subjected to genomic, epigenetic and proteomic analyses. Assay results will be reported to the central study data base for scientific analyses. In addition, biomarker results obtained by NGS-based panel sequencing of tumor- and plasma-derived DNA will be reported back to the clinical investigators of the AIO-TRK-0114 (MARBLE) study, and can be shared with the study patients.

Eligibility: Inclusion Criteria:
  1. Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
  2. Written informed consent
  Exclusion Criteria:
  1. Patients who do not meet the inclusion criterial of the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

Summary: This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Detailed description: This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), MTD/RP2D (maximum tolerated dose/recommended phase 2 dose) and preliminary efficacy of DS-6051b will be evaluated.

Eligibility: Inclusion Criteria:
  -  Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
  -  An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  Exclusion Criteria:
  -  Previously had or currently has any of the following diseases:
  Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
  -  Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
  -  Severe or uncontrolled concomitant disease.
  -  Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy

Summary: Objective:
  To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
  In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.

Detailed description: Primary end-point:
  Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
  Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
  1. There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
  2. There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.

Eligibility: Inclusion Criteria:
  -  Men suitable for monotherapy with permanent Iodine 125 implant
  -  Age > 50 yrs
  -  PS 0-2 (WHO)
  -  Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
  -  No more than 50% of cores involved (summary)
  -  MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
  -  Gleason sum no greater than 3+4 =7 in any core
  -  Clinical T stage no higher than T T (tumor) 2A
  -  Prostate volume ≤60 cc
  -  Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
  -  No prior history of malignancy except non-melanoma skin cancer
  -  Must be suitable for general or spinal anesthesia
  Exclusion Criteria:
  Have anesthesia surgical assignment category IV or greater
  -  Cannot cease anti-coagulant therapy
  -  Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
  -  urethral stricture
  -  Prior prostate cancer therapies

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Summary: Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

Detailed description: The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
  The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Eligibility: Inclusion Criteria:
  1. Aged 18 years old or more
  2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
  3. No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
  4. Patient able to stand a blood collection.
  5. Patient explanation given and consent information signed or by legal representative.
  Exclusion Criteria:
  6. Patient without social protection / insurance..
  7. Patient with hepatic metastasis unresectable by surgery
  8. Patient with extra-hepatic metastasis.
  9. Person deprived of liberty or under guardianship
  10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

Summary: Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

Detailed description: This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
  The patient will have a blood sample at the following times :
  -  T0: before treatment of the primary tumor.
  -  T1: 1 months after the end of the local treatment.
  -  T2: at 7 months.
  -  Tn: every 6 months up to 3 years.

Eligibility: Inclusion Criteria:
  -  Aged 18 years old or more.
  -  Patient with a recent choroidal melanoma before the start of the specific treatment.
  -  Patient able to stand a blood collection.
  -  Work-up for extension (CT).
  -  Patient explanation given and consent information signed or by legal representative
  Exclusion Criteria:
  -  Patient without social protection / insurance.
  -  Person deprived of liberty or under guardianship.
  -  Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

Summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility: Inclusion Criteria
  Patient:
  -  Men aged 20 to 65 years
  -  Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
  -  With an AHI > 5 / h
  Healthy volunteers:
  -  Men aged 20 to 65 years
  -  With an AHI ≤ 5 / h
  Exclusion Criteria
  All subjects:
  -  Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
  -  Known cardiovascular disease associated (heart failure, rhythm disorder ...)
  -  Known respiratory diseases
  -  Known neoplastic pathology, known chronic inflammatory disease
  -  Psychiatric pathology treated
  -  Medication
  -  Not affiliated to the French social health care system
  -  Major protected person
  -  Private person of liberty
  -  People in emergency situation
  -  Patient refusing to participate in the study

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: HOPE Social Media Intervention for HIV Testing and Studying Social Networks

Summary: This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on online social networks such as Facebook.com. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through online social networks. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Male
  -  Sexually active with another man in the last 12 months
  -  Willing and capable of understanding and assenting to an online informed consent form
  -  Has (or willing to create) a social media page.
  Exclusion Criteria:
  -  Does not satisfy inclusion criteria

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma


Eligibility: Inclusion criteria Part 1: Safety run-in
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  -  ECOG performance status ≤ 1
  Part 2: Biomarker cohort
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  -  ECOG performance status ≤ 2
  Part 3: Double-blind, randomized, placebo-controlled part
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  Part 1: Safety run-in
  -  Subjects with uveal or mucosal melanoma
  -  Any history of CNS metastases
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
  -  Subjects with uveal or mucosal melanoma
  -  Clinically active cerebral melanoma metastasis
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Other protocol-defined Inclusion/Exclusion may apply.

Relevance to patient case: not relevant