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

Clinical trial: Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed description: Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Eligibility: Inclusion Criteria:
  -  Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
  -  Tumor EGFR mutation
  -  Presence of measurable disease by RECIST
  -  stage IIIA or IIIB, non-resectable
  -  ECOG performance status 0-2
  -  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 except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  Any other morbidity or situation with contraindication for radiotherapy (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 7 days before the first administration) and pregnant women
  -  Women and men of childbearing potential who have no willing of employing adequate contraception
  -  Tumor EGFR wild

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

Clinical trial: A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer

Summary: The purpose of this study is:
  1. To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer
  2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways
  Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively.
  Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted.
  A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection.
  Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.


Eligibility: Inclusion Criteria:
  Exclusion Criteria:

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

Clinical trial: An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Summary: This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of malignancy other than NSCLC
  -  positive for translocation or inversion event involving the ALK gene locus
  -  positive for ALK amplification events
  -  positive for ALK activating point mutations
  Exclusion Criteria:
  -  mutations of amplifications involving the c-Met gene but not the ALK gene
  -  concurrent treatment on another therapeutic clinical trial
  -  prior therapy specifically directed against ALK

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

Clinical trial: Validation of a Multi-gene Test for Lung Cancer Risk

Summary: The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.

Detailed description: Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Eligibility: Inclusion Criteria:
  -  20 or more pack year smoking history
  -  clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
  Exclusion Criteria:
  -  Lung Cancer within 3 months after the date of enrollment

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

Clinical trial: A Retrospective Pharmacoeconomic Study of Lung Cancer

Summary: Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed at late stage, not amenable to surgical resection. With the introduction of new targeted agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations, lung cancer management has markedly changed in recent years. However, these new agents are costly and their payment is restricted in certain situations defined National Insurance Agency. Therefore, using databases from National Insurance Agency might not be able to reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze the data from a tertiary medical center, where all the costs including insurance reimbursement, co-payment, and payment not covered by insurance. The investigators will also compare with the investigators results with national database to analyze the cost benefit of these new agents on lung cancer.


Eligibility: Inclusion Criteria:
  -  lung cancer patients in WanFang Hospital
  Exclusion Criteria:
  -  non

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

Clinical trial: Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Summary: Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.
  Exclusion Criteria:
  -  non

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

Clinical trial: Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Summary: Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

Detailed description: All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
  Three study groups are defined using the following inclusion and exclusion criteria:
  -  lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
  -  healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
  -  chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
  For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
  Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
  -  5 BS are presented in 1 experiment:
  -  Test I: lung cancer vs healthy individual
  -  Test II: lung cancer vs chronic obstructive pulmonary disease
  -  Test III: lung cancer vs healthy individuals & bronchitis
  -  for every experiment 1 BS of a lung cancer patient is used
  -  the lung cancer sample is placed randomly in one of the five test tubes
  -  the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  -  neither the dog handler nor the dog know the loading of the test tubes
  -  experiments are repeated 5 to 10 times
  For analysis, the sensitivity and specificity of the dog's reaction is determined.
  The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Eligibility: Inclusion Criteria:
  -  age 18-80
  -  competent
  -  confirmed lung cancer
  Exclusion Criteria:
  -  history of other cancers

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

Clinical trial: A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Summary: This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.


Eligibility: Inclusion criteria:
  1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
  2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
  Exclusion criteria:
  1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
  2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
  3. Known pre-existing interstitial lung disease.
  4. Planned major surgical procedures during the trial period.

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

Clinical trial: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  -  Metastatic disease treated with gefitinib or erlotinib
  -  Presence of at least one measurable lesion according to RECIST criteria
  Exclusion Criteria:
  -  No tumor tissue available
  -  No clinical data available

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

Clinical trial: A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

Summary: This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.


Eligibility: Inclusion Criteria:
  -  Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.
  -  For subjects with non-small cell lung cancer only:
  -  Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
  -  A documented mutation in EGFR exons 19 or 21
  -  Subjects must have no further standard of care options or have refused standard therapy
  -  Measurable or evaluable disease
  -  Age ≥ 18 years
  -  ECOG performance < 2
  -  Life expectancy ≥ 3 months
  -  If female, neither pregnant or lactating
  -  If of child bearing potential, must use adequate birth control
  -  Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
  -  Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
  -  Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
  -  Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
  -  Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
  -  Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
  -  Able to render informed consent and to follow protocol requirements.
  Exclusion Criteria:
  -  Anticancer therapy within 4 weeks of study entry.
  -  Use of investigational agent(s) within 30 days of study entry
  -  History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
  -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Subjects with liver cancer and hepatitis may be eligible.

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

Clinical trial: Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer

Summary: A large project consisting of:
  a) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.

Detailed description: Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
  This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
  This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.

Eligibility: Inclusion Criteria:
  -  clinical diagnosis of lung cancer
  Exclusion Criteria:
  -  refusal Consent
  -  inability to provide exhaled CO
  -  active psychiatric illness or substance misuse
  -  concurrent malignancies of another type other than non-melanoma skin cancer
  -  unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
  -  WHO performance status 4
  -  Life expectancy less than 6 weeks.

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

Clinical trial: Pemetrexed in Advanced Non-small Cell Lung Cancer

Summary: Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution
  -  Patients treated with single agent pemetrexed for metastatic disease
  -  Availability of full clinical data
  Exclusion Criteria:
  -  Cytological diagnosis of advanced Non-small cell lung cancer
  -  Lack of tumor tissue at our institution
  -  Lack of full clinical data

Relevance to patient case: not relevant