araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

Summary: Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC

Detailed description: Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment

Eligibility: Inclusion Criteria:
  -  Histopathologic diagnosis of non small-cell lung cancer
  -  Clinical stage IIIA and/or IIIB without pleural effusion
  -  ECOG functional status 0 or 1
  -  No renal function alteration (GFR >50%)
  -  No hepatic function alteration (ALT and AST less than 2 times its normal value)
  -  Leucocytes more than 2,000/mcl
  -  Hemoglobin more than 10mg/dL
  -  Platelets more than 100,000/mcl
  Exclusion Criteria:
  -  Ischemic heart disease
  -  Abnormal electrocardiogram

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)

Summary: The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.


Eligibility: Inclusion Criteria:
  -  At least 18 years old
  -  Male and female patients
  -  Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC
  -  Therapy with Navelbine capsules in any palliative treatment line
  -  Signed patient informed consent
  Exclusion Criteria:
  -  Pregnancy and nursing
  -  All other exclusion criteria listed in SPC (summary of product characteristics)
  -  lack of signed Patient informed consent

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

Summary: RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.
  PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

Detailed description: OBJECTIVES:
  -  To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
  -  To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.
  OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

Eligibility: DISEASE CHARACTERISTICS:
  -  Healthy participant
  -  No history of smoking
  -  No history of cancer
  PATIENT CHARACTERISTICS:
  -  SWOG performance status 0
  -  No clinically apparent bleeding diathesis
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers

Summary: RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.

Detailed description: OBJECTIVES:
  -  Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.
  -  Correlate protein levels with the largest difference in peptide matches in sera in these participants.
  OUTLINE: This is a prospective study.
  Participants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.
  PROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Diagnosis of squamous cell carcinoma of the head and neck
  -  Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Tumor Samples From Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the correlation between c-Met expression, mutation and amplification, with stage and overall survival in patients with adenocarcinoma (AC) of the lung.
  Secondary
  -  To determine the correlation with epithelial mesenchymal transition (EMT), EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, loss of heterozygosity (LOH), DUB3 expression & regulation, and ALK translocation, with respect to survival.
  -  To determine the correlation with circulating c-Met and HGF in AC and evaluate prognostic implications of circulating markers in AC of lung.
  -  To determine (when available) levels of circulating Met and HGF in serum before and after surgery.
  OUTLINE: This is a multicenter study.
  Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, and K-ras. DNA is examined by PCR, followed by agarose gel electrophoresis; gene amplification of c-Met is examined by real time quantitative PCR; met/HF protein in serum is examined by ELISA; and c-Met, EGFR, p53, c-CBL, DUB3 enzyme, and ALK, and epithelial mesenchymal transition examined by IHC.

Eligibility: Inclusion Criteria:
  -  Registration to Cancer and Leukemia Group B (CALGB) 140202
  -  Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
  -  Informed consent: the CALGB does not require that a separate consent form be signed for this study
  -  The subject population to be studied in this protocol includes patients selected from CALGB 140202; all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
  -  All samples to be studied were obtained and stored as part of CALGB 140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
  -  There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
  -  All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
  -  This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
  -  Investigate EGFR DNA copy-number changes.
  -  Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.
  OUTLINE: This is a multicenter study.
  DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

Eligibility: DISEASE CHARACTERISTICS:
  -  Eligible for and concurrently enrolled on clinical trial CASE-2507
  PATIENT CHARACTERISTICS:
  -  Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  -  Normal coagulation profile and platelet count > 100,000/mm³*
  -  Not pregnant NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin)
  -  No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)* NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Summary: Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.


Eligibility: Inclusion Criteria:
  -  The patient has pathologically proven hepatocellular carcinoma (any stage)
  -  All the data required are available from patient's records
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
  PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
  Secondary
  -  Determine the progression-free survival in patients treated with this regimen.
  -  Determine the overall survival in patients treated with this regimen.
  -  Determine the safety and tolerability of this regimen in these patients.
  -  Determine the psycho-neurological effects of this regimen in these patients.
  -  Determine the quality of life of patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
  -  Group 1: Patients undergo prophylactic brain radiotherapy.
  -  Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
  After completion of study therapy, patients are followed up periodically.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed non-small cell lung cancer
  -  Stage IIIB or IV disease
  -  Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
  -  At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
  -  Stable disease allowed provided 1 of the following criteria is met:
  -  EGFR mutation (exon 19 or 21)
  -  Having ≥ 2 of the following 3 factors:
  -  Female
  -  Never smoked
  -  Histologically confirmed adenocarcinoma of the lung
  -  No evidence of brain metastases by CT scan or MRI within the past 4 weeks
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  ANC ≥ 1,500/mm^3
  -  Platelet count ≥ 150,000/mm^3
  -  Bilirubin < 1.5 mg/dL
  -  Serum creatinine < 1.5 times upper limit of normal
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Received 1 or 2 prior systemic chemotherapy regimens

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.
  PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.
  This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study

Detailed description: Pilot Study- Primary Objectives:
  -  Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
  -  Rate of PET-CT Scan based treatment delivery
  Pilot Study- Secondary Objectives:
  -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
  Phase II Study- Primary Objective:
  -The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.
  Phase II Study- Secondary Objectives:
  -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Eligibility: Inclusion Criteria:
  -  Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
  -  TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
  -  Measurable disease
  -  No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
  -  Patient suitable for radical 3-DCRT
  -  ECOG-Performance status ≤ 2 / KPS > or equal to 60
  -  Weight loss <10% within the 3 months prior to diagnosis
  -  No prior radiotherapy to the thorax
  -  Patient is suitable for lung-board immobilisation
  -  No chemotherapy received prior to planning PET-CT scan
  -  Age 18 and over
  -  Provision of written informed consent
  Exclusion Criteria:
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
  -  FEV1 < 1

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)

Summary: This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.


Eligibility: Inclusion Criteria:
  -  adult patients over 18
  -  non small cell lung cancer histologically or cytologically proved
  -  Clinical Stage IIIA
  -  anatomically and functionally resectable
  Exclusion Criteria:
  -  uncorrected bleeding disorders
  -  absence of lymphadenopathy superior to 1cm in small axis at CT scan
  -  contraindication to bronchoscopy
  -  extrathoracic or intrathoracic metastasis
  -  respiratory function tests not compatible with curative resection of lung cancer

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Summary: This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
  -  Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  -  Life expectancy greater than or equal to (>=) 12 weeks
  -  Adequate hematologic and end organ function
  -  Agreement to use an effective form of contraception for the duration of the study
  Exclusion Criteria:
  -  History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
  -  History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment
  -  Allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations
  -  Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
  -  Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
  -  Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
  -  Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1
  -  History of diabetes requiring daily medication, or history of Grade >= 3 fasting hyperglycemia
  -  Current severe, uncontrolled systemic disease
  -  History of clinically significant cardiac or pulmonary dysfunction
  -  History of malabsorption or other condition that would interfere with enteral absorption
  -  Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
  -  Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
  -  Active autoimmune disease
  -  Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
  -  Pregnancy, lactation, or breastfeeding
  -  Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  -  No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Relevance to patient case: not relevant