araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas

Summary: The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.


Eligibility: Main inclusion criteria:
  -  Patients with grade III or IV glioma newly diagnosed with histological evidence
  -  Surgical indication
  -  Tumor tissue available at biobank of Lille
  -  Men and women aged ≥ 18 years
  -  Informed Consent signed by the patient or his legal representative.
  Main exclusion criteria:
  -  Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix
  -  Previous history of brain radiotherapy
  -  Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma
  -  Genetic disease that may cause brain tumor, potentially radiation-induced tumor
  -  History of degenerative neurological disease prior to diagnosis
  -  contraindication to MRI

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: LIquid BIopsies in Lung Cancer (LIBIL)

Summary: The goal of this project is to create a biological collection of blood samples from patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.


Eligibility: COHORT 1
  Inclusion Criteria:
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
  -  Inclusion at the time of diagnostic
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion Criteria:
  - Patients treated before their liquid biopsy
  COHORT 2 Inclusion criteria
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
  -  Inclusion at the time of diagnostic during follow-up or at relapse
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion criteria
  - Patients treated before their liquid biopsy

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: CTCs for High Grade Glioma

Summary: The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.


Eligibility: Inclusion Criteria:
  -  Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
  -  Age 18 or older
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Summary: Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

Detailed description: The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.
  FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.

Eligibility: Inclusion Criteria:
  -  Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
  -  Undergoing thyroid surgery (histology of index nodule)
  Exclusion Criteria:
  -  Not undergoing thyroid surgery

Relevance to patient case: possibly relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Summary: The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Detailed description: Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.
  Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Eligibility: Inclusion Criteria:
  -  Age > 18 years
  -  Karnosky performance status (KPS) ≥70
  -  Patients aged >70 years with KPS ≥80
  -  Histopathologically confirmed grade III-IV glioma
  -  Estimated survival ≥ 3 months
  -  Any Tumor volume
  -  Unifocal tumor
  -  Interval time from previous radiotherapy ≥ 6mesi
  -  Normal liver, Kidney and bone marrow function
  -  Written informed consent
  Exclusion Criteria:
  -  KPS < 70
  -  Multifocal tumor
  -  Other primary cancer
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Summary: This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
  In addition, this is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Eligibility: Inclusion Criteria:
  1. Must have a clinical diagnosis of Glioblastoma (GBM)
  2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue
  3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100 (N/A to the sub-study)
  4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery
  5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)
  Exclusion Criteria:
  1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and gliomatosis cerebri but can't have recurrent or metastatic GBM )
  2. Prior chemo therapy or radiosensitizer for head and neck cancer.
  3. Prior radiotherapy to the head or neck in overlap of radiation fields.
  4. Prior therapy for glioblastoma or other invasive malignancy.
  5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

Summary: This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.


Eligibility: Inclusion Criteria:
  -  Japanese participants with WHO grade III or IV malignant glioma in Phase 1 portion or WHO grade IV GBM in Phase 2 portion
  -  70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
  -  80 or above on Karnofsky Performance Status in Arm B of Phase 1 portion
  -  Adequate bone marrow function
  -  Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion
  -  Histologically proven newly diagnosed malignant glioma in Arm B of Phase 1 portion
  -  Participants must have confirmed EGFR amplification by central lab in Phase 2 portion
  Exclusion Criteria:
  -  Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion)
  -  Anti-cancer treatment prior to study Day 1 for Arm B of Phase 1 portion
  -  Participant has received prior treatment with bevacizumab, for recurrent glioblastoma, EGFR therapy or has secondary grade IV GBM in Phase 2 portion
  -  Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Summary: This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.


Eligibility: Inclusion Criteria:
  -  Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
  -  Written informed consent granted
  Exclusion Criteria:
  - Do not fulfill one or more inclusion criteria

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Phase II Pediatric Study With Dabrafenib in HGG Patients

Summary: The purpose of this study is to investigate the activity of dabrafenib in children and adolescent patients with BRAF V600 mutation positive relapsed or refractory high grade glioma.


Eligibility: Inclusion Criteria:
  -  Diagnosis of High Grade glioma
  -  Relapsed, progressed or failed to respond to frontline therapy.
  -  Able to swallow capsules
  Exclusion Criteria:
  -  Previous treatment with dabrafenib
  -  Cancer treatment within the past 3 weeks
  -  Stem cell transplant within the past 3 months
  -  History of heart disease
  -  Pregnant or lactating females

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Study of the Anti-tumoral Immune Response

Summary: This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.


Eligibility: Inclusion Criteria:
  -  Performance status 0,1 or 2
  -  breast cancer or glioma
  -  Arm glioma: patients without anti-tumoral treatment
  -  Arm breast cancer: inclusion before treatment
  -  Arm breast cancer HER2: patients with current therapy
  Exclusion Criteria:
  -  Psychiatric disease compromising the understanding of the information or the realization of the study
  -  vulnerable People according to the law (minors, adults under protection, private persons of freedom ...)
  -  Unaffiliated People to the Social Security
  -  People being for the period of exclusion from another study
  -  Life expectancy estimated unless 3 months.
  -  For patients in Arm glioma: patients having already begun a systematic treatment.
  -  For patients with a breast cancer: patient already under current therapy

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Summary: A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

Detailed description: Patient characteristics, tumour characteristics including the BRAF mutation status and baseline serum S100B and LDH levels of each patient will be retrospectively determined from the electronical patient file. In each patient, tumour burden and 18F-FDG uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18F-FDG-PET scan. Tumour burden will also be measured on the baseline contrast enhanced CT scan. The correlation of each FDG-PET parameter with baseline LDH and S100B levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Eligibility: Inclusion Criteria:
  - All patients >18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IV melanoma) treated in the UMCG between May 2014 and December 2015.
  Exclusion Criteria:
  -  participation in interventional studies
  -  missing baseline 18F-FDG PET scan and/or baseline contrast enhanced CT scan
  -  missing baseline serum LDH level
  -  missing BRAF mutation status, concurrent malignancies or a history of previous malignancies.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

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: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

Summary: This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed GBM (WHO grade IV).
  -  The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
  -  Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
  -  Karnofsky performance status (KPS) of at least 60%.
  -  Willing to remain abstinent from consuming alcohol.
  -  Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
  -  Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
  -  11. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  Exclusion Criteria:
  -  Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
  -  Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
  -  Received more than one course of radiation therapy or more than a total dose of 75 Gy.
  -  History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
  -  Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
  -  Fever within 3 days prior to study enrollment.
  -  Active or severe hepatic or renal disease.
  -  Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
  -  History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
  -  History of Wilson's disease.
  -  History of hemochromatosis.
  -  Pregnant or breastfeeding.

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Seizure Treatment in Glioma

Summary: Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studiessupporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Detailed description: Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.
  Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.

Eligibility: Inclusion Criteria:
  -  Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS.
  -  Adult patients: ≥18 years of age
  -  First epileptic seizure, no longer than 2 weeks ago
  -  Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
  -  Willing to provide written informed consent
  Exclusion Criteria:
  -  Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
  -  History of non-brain tumor related epilepsy
  -  Pregnancy
  -  History of a status epilepticus
  -  Presence of contra-indications for use of levetiracetam or valproic acid

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

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