araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)

Summary: Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).


Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
  -  Presence of measurable disease by RECIST
  -  Inoperable stage IIIA or IIIB
  -  ECOG performance status 0-1
  -  No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
  -  Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  Carcinoid tumor, small cell carcinoma of lung
  -  Patients with any distant metastasis
  -  History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
  -  Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

Summary: RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

Detailed description: OBJECTIVES:
  -  Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
  -  Correlate mutations with time to progression and survival of these patients.
  OUTLINE: This is a multicenter study.
  Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.
  PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:
  -  Recurrent disease
  -  Stage IIIB with pleural or pericardial effusion
  -  Stage IV disease
  -  Treated on protocol ECOG-2598
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Identifying Early Lung Cancer Cells in Malignant Pleural Effusion Samples From Patients With Primary Lung Cancer

Summary: RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer may help doctors identify early lung cancer cells. It may also help the study of lung cancer in the future.
  PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients with primary lung cancer to see if early lung cancer cells can be identified.

Detailed description: OBJECTIVES:
  -  Isolate and identify lung cancer precursor cells in discarded pleural fluid specimens obtained during routine thoracentesis procedures for the diagnosis and treatment of malignant pleural effusions.
  OUTLINE: Malignant pleural effusion specimens obtained from the Pathology Department at the University Hospitals of Cleveland are analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin. The isolated cells are then stained with fluorescent DNA binding dye, Hoechst 33342, and other markers (i.e., CD133, CD24/CD44) and sorted by flow cytometry into progenitor and nonprogenitor subpopulations. The sorted subpopulations are separated and examined functionally by in vitro and in vivo studies. Sphere culture studies are also performed on the sorted subpopulations. The specimens may also be utilized for transcriptional profiling studies, RNAi studies, and for the establishment of long-term cultures and cell lines. DNA is also isolated and stored from tumor and nonepithelial normal cell compartments for future genetic studies on known and unidentified genetic abnormalities contributing to the development of lung cancer, such as EGFR, ErbB2, K-ras, and p53 mutational status.

Eligibility: DISEASE CHARACTERISTICS:
  -  Cytologically positive malignant pleural effusion secondary to primary small cell or non-small cell lung cancer
  -  Recruited from the Division of Hematology/Oncology, the Multidisciplinary Thoracic Oncology Group of Ireland Cancer Center, or the inpatient or outpatient units of Case Medical Center-University Hospitals
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

Summary: RATIONALE: Studying samples of 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 research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

Detailed description: OBJECTIVES:
  -  Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.
  -  Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.
  OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.

Eligibility: Inclusion Criteria:
  Non-Small Cell Lung Cancer Patients
  -  Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
  -  Measurable disease by CT scan within the past 4 weeks
  Healthy volunteer
  -  Non-smoking, defined as < 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker
  -  Not regularly exposed (i.e., daily) to second-hand smoke
  Exclusion Criteria:
  -  Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV_1 < 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.
  Written consent must be given for both subjects and controls.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying samples of 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. It may also help doctors predict how patients respond to treatment with erlotinib.
  PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
  -  Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
  -  Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
  -  Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.
  OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.
  PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer, including any of the following subtypes:
  -  Adenocarcinoma
  -  Squamous cell carcinoma
  -  Bronchoalveolar carcinoma
  -  Carcinoid
  -  Stage IIIB or IV or recurrent disease
  -  Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.

Detailed description: OBJECTIVES:
  -  To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
  -  To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
  -  To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.
  OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment [by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.
  After completion of study, patients will be followed until their death.

Eligibility: Inclusion criteria
  -  Diagnosis of suspected lung cancer or lung cancer
  Exclusion criteria
  -  Inability to undergo therapy

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)

Summary: RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath from patients who have or are at high risk for lung cancer and from healthy participants.

Detailed description: OBJECTIVES:
  -  To evaluate the ability of proteomic patterns in serum and exhaled breath condensate samples to detect and discriminate lung cancer from healthy and from high-risk individuals.
  -  To correlate proteomic patterns with tumor behavior.
  OUTLINE: This is a multicenter study.
  Blood and exhaled breath condensate samples are collected, whenever possible, at a time medically indicated for other purposes (e.g., work-up, pre-op, surgical procedures). The samples are used to produce genetic material (i.e., DNA, RNA) and molecular material (i.e., proteins) that will be stored for future studies, including studies that may not be related to lung cancer. Future genetic studies related to lung cancer may include studies of protein expression patterns via matrix-assisted laser desorption/ionization time of flight mass spectrometry that may serve as predictive molecular markers of lung cancer.
  Participants complete a 15-minute Lung Spore Database questionnaire at the time of study enrollment to provide information on demographics (e.g., date of birth, address, phone number), medical and smoking history, personal and family history of cancer and cancer treatment, and current medications. Medical records are reviewed at the time of study enrollment and then over approximately 5 years to obtain information, including test results, associated with the diagnosis of cancer. Participants may also be contacted by phone at a later time to answer questions about their health status.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Normal healthy volunteer
  -  At high risk for lung cancer (e.g., > 30-pack year history of smoking; chronic obstructive pulmonary disease; or disease-free after surgical resection of lung cancer)
  -  Diagnosis of stage I, II, IIIA, IIIB, or IV lung cancer
  -  Must be willing to allow blood and exhaled breath condensate samples to be stored for genetic testing
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Summary: RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Detailed description: OBJECTIVES:
  -  To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
  -  To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.
  OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
  Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Eligibility: Inclusion Criteria:
  -All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
  Exclusion Criteria:
  -  Inability to provide informed consent
  -  Minors
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lapatinib Resistance in Patients With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
  PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

Detailed description: OBJECTIVES:
  -  To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
  -  To investigate ErbB2 copy number changes and expression levels.
  -  To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
  OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
  NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically confirmed invasive breast cancer
  -  ErbB2-positive disease
  -  Has received or is currently receiving lapatinib ditosylate
  -  Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
  -  Must have tumor tissue samples available for research studies
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Not pregnant*
  -  Coagulation profile normal*
  -  Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
  -  No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
  -  No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Prognosis of Lung Transplant Candidates

Summary: The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Detailed description: The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Eligibility: Inclusion Criteria:
  -  New lung transplant candidates
  Exclusion Criteria:
  -  Heart and lung transplant candidates
  -  Uncontrolled severe comorbidities

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Summary: This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2.
  In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.

Detailed description: The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Part 1 as communicated to investigators on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not terminated due to safety reasons.

Eligibility: Inclusion Criteria:
  Part 1:
  -  Ages eligible for study: 18 years or older.
  -  Male and female.
  -  Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
  Part 2:
  -  Ages eligible for study: 18 years or older.
  -  Female.
  -  Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
  -  Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently analyzed biopsy.
  Exclusion Criteria:
  Part 1:
  -  Prior bosutinib, or any other prior Src inhibitor.
  -  Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity.
  Part 2:
  -  Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
  -  Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months.
  -  erbB2+ breast cancer.

Relevance to patient case: not relevant