araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)

Summary: Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.

Detailed description: The aim of this study is to study blood circulating levels bone-marrow-derived progenitor cells (EPCS).
  In a first phase, EPCs will be detected in healthy non-smokers volunteers to validate flow cytometry method (n=25). In addition, EPC will e characterized by primary cultures to analyze EPC-specific markers.
  In a second phase, EPCs will detect in peripheral blood from 50 patients with Chronic Obstructive Pulmonary Disease (COPD) and 50 patients with non-small cell lung cancers (NSCLC). Primary cultures will be made to confirm EPCS isolation.
  Methods: EPCs will be numerated by flow cytometry using CD133, CD146, CD34, CD45 and VEGFR2 antibodies. Primary cultures will be used to identify EPCs at 5-days culture by the same markers. In addition, for BPCO et NSCLC patients, Vascular endothelial cell growth factor (VEGF) concentration will be measured in peripheral sera by ELISA commercial test.
  Overall survival will be analyzed for NSCLC in function of initial EPCs concentration. Correlation will be studied between initial VEGF serum concentration and EPCs level.
  This study focus on the possibility that EPC determination in peripheral blood could be used as a surrogate marker of standard or antiangiogenic treatment in NSCLC.

Eligibility: Inclusion Criteria:
  -  Signed written consent
  -  Subject > 18 year old
  -  No precedent therapy for cancer
  -  Non-smoker healthy subject or current smoker COPD patients or NSCLC patients
  Exclusion Criteria:
  -  Small-cell lung cancer patient
  -  Radiotherapy, chemotherapy or target therapy for NSCLC

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Summary: Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age.
  Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.
  The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes.


Eligibility: Inclusion Criteria:
  -  Stable weight (< 5% variation) within the last three months
  -  Age: 35 to 50 years old for middle-age group, and 65 to 80 years old for elderly group.
  -  BMI: 20 to 29.9 kg/m2
  -  Normal glucose tolerance (NGT) for groups Elderly and Middle-age
  Exclusion Criteria:
  -  Use of estrogen, progestogen or systemic corticosteroids.
  -  Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
  -  Smoking
  -  Obesity
  -  Uncontrolled systemic or debilitating diseases

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors

Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Abdominal compression methods that hold the body and the tumor from moving during treatment may permit radiation therapy to kill more tumor cells. This study is looking at the comfort level of two abdominal compression methods in patients with lung tumors undergoing stereotactic body radiation therapy.
  PURPOSE: This phase I trial is studying the comfort level of two abdominal compression methods used to hold patients still while undergoing stereotactic body radiation therapy for lung tumors.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate comfort associated with the existing screw-based abdominal compression device and the new automated abdominal compression device in patients with lung tumors undergoing stereotactic body radiotherapy.
  Secondary
  -  To evaluate tumor motion in patients using these devices.
  OUTLINE: This is a multicenter study.
  Patients undergo fluoroscopic assessment of tumor motion with a screw-based abdominal compression device. Patients then undergo non-contrast 4D-CT imaging with the screw-based abdominal compression device followed by contrast 4D-CT imaging with an automated abdominal compression device.
  Immediately after stereotactic body radiotherapy simulation, patients complete a questionnaire to assess the overall level of comfort of each abdominal-compression device.

Eligibility: DISEASE CHARACTERISTICS:
  -  All lung patients from the University of Texas Southwestern Medical Center, Parkland Health and Hospital System, and Richardson Regional Cancer Center scheduled to receive stereotactic body radiotherapy simulation
  -  Must have initial pre-compression lung tumor motions with respiration > 1 cm
  PATIENT CHARACTERISTICS:
  -  Negative pregnancy test
  PRIOR CONCURRENT THERAPY:
  -  Concurrent participation in other protocols allowed

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Patients With Lung Cancer Who Have Not Received Chemotherapy Before

Summary: The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Detailed description: Participants with Stage IIIb or IV NSCLC who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus [vs.] nonsquamous).

Eligibility: Inclusion Criteria:
  -  Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
  -  Has metastatic disease
  -  Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
  -  Has adequate hematologic function
  -  Has adequate hepatic function
  -  Has adequate renal function
  -  Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  Exclusion Criteria:
  -  Has uncontrolled brain metastases
  -  Has leptomeningeal disease
  -  Has received previous chemotherapy for NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
  -  Receiving any other investigational agent(s)
  -  Has a history of treatment with other agents targeting the IGF or the EGF receptor
  -  Has a known allergy / history of hypersensitivity reaction to any of the treatment components
  -  Has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose < 160 mg/dL or below the ULN and hemoglobin A1C ≤ 7%) and that they are on a stable dietary or therapeutic regimen for this condition
  -  Has an uncontrolled intercurrent illness
  -  Pregnant or lactating
  -  Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
  -  Has superior vena cava syndrome contraindicating hydration
  -  Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
  -  Has any NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy
  -  Has significant third space fluid retention, requiring repeated drainage

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer

Summary: RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
  PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
  -  To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
  Secondary
  -  The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
  Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.

Eligibility: INCLUSION CRITERIA:
  -  At least 18 years of age or older
  -  Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
  -  Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment
  EXCLUSION CRITERIA:
  -  Patients with a pneumonectomy
  -  Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
  -  Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan
  -  Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension
  -  Patients taking lithium
  -  Currently smoking or smoked within 6 months of study entry
  -  Pregnant, intending to become pregnant or breastfeeding
  -  Baseline systolic blood pressure < 100 mmHg
  -  History of lung transplant
  -  History of kidney failure or liver disease
  -  Inability to attend clinic visits

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

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

Detailed description: OBJECTIVES:
  -  Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches.
  -  Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy.
  -  Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival.
  OUTLINE: This is a multicenter study.
  Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis.
  Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.

Eligibility: Inclusion criteria
  -  Diagnosis of non-small cell lung cancer
  -  Clinical stage I and II disease
  -  Resectable disease and complete surgical resection planned
  -  Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network
  -  Tumor specimen samples must be available at resection
  Exclusion criteria
  -  Chemotherapy before surgery
  -  Radiotherapy before surgery

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood 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 tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

Detailed description: OBJECTIVES:
  -  Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer.
  -  Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients.
  OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed lung cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  May have received prior EGFR inhibitors

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer

Summary: This research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed description: OBJECTIVES:
  1. To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.
  2. To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.
  3. To associate these specimens with historical, clinical, pathological, and outcome information.
  Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.

Eligibility: 1. Histologic Documentation: All patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a CALGB-sponsored treatment trial; patients enrolled on a CALGB trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on CALGB 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible.
  2. No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility: Inclusion Criteria:
  1. Female presenting with metastatic breast cancer.
  2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
  3. HER2 and HR status must have been determined.
  4. Patients must have HER2 negative breast cancer.
  5. Patients must have a documented disease progression as define by RECIST at baseline.
  6. Patients with HR+ disease:
  -  Must have received at least one prior endocrine therapy in the metastatic setting.
  -  Must have received no more than three lines of chemotherapy in the metastatic setting.
  7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
  Exclusion Criteria:
  1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  -  History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
  -  Clinically significant resting bradycardia (< 50 beats per minute).
  -  LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
  3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: DNA Chip Based Prognosis of Lung Cancer

Summary: The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).


Eligibility: Inclusion Criteria:
  1. A histological diagnosis of primary NSCLC stage Ia
  2. Surgical removal of the tumor
  3. Age between 18 and 75 years
  4. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
  2. Adjuvant treatment with chemotherapy.
  3. Prior history of cancer in the past 5 years or breast cancer at any time.
  4. Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
  Secondary
  -  To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
  OUTLINE: This is a multicenter study.
  Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following advanced metastatic malignancies:
  -  Malignant melanoma
  -  Lung cancer
  -  Breast cancer
  -  Pancreatic carcinoma
  -  Colorectal cancer
  -  Advanced and/or metastatic disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant