araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)

Summary: Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.
  Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.

Detailed description: The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.
  The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed lung cancer and tissue availability for ALK analysis.
  Exclusion Criteria:
  -  Not lung cancer

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: LIquid BIopsies in Lung Cancer (LIBIL)

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


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

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

Summary: A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.

Detailed description: The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24 public and private mental health practices in the Greater Cincinnati and New York City regions, (approximately 900 each from ~12 Cincinnati region and ~12 Long Island/New York mental health treatment sites) to participate in the proposed patient-centered large pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%), continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate will be 2-3 patients/month/site for a recruitment time of 30 months.

Eligibility: Inclusion Criteria:
  1. Inpatient or outpatient age 8-17 years inclusive;
  2. Fluent in English;
  3. Diagnosed by a clinician with a bipolar spectrum disorder (BSD), i.e., bipolar I, bipolar II, bipolar or mood disorder not otherwise specified, cyclothymic disorder or other specified bipolar or mood disorder;
  4. Body mass index >85%ile for age and sex by standard growth charts;
  5. Received a new or ongoing prescription for at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine)
  Exclusion Criteria:
  1. Prior intolerance or ineffective exposure to Metformin (MET); No exposure in past 12 month will be permitted;
  2. Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
  3. Fasting glucose > 125 mg/dL on 2 occasions during screening indicating need for prompt treatment;
  4. Serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;
  5. Pregnant or breast feeding;
  6. Children with caregivers who are unable to complete assessments of the child for any reason;

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

Summary: MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

Detailed description: If testing has not already been performed, the study will provide for the testing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of non-small cell lung cancer
  -  Metastatic or locally advanced disease
  -  Prior platinum chemotherapy or immunotherapy
  -  Test result showing genetic change in MET tumor gene
  -  At least one tumor that can be measured on a radiographic scan
  Exclusion Criteria:
  -  Prior treatment with inhibitor of MET or HGF
  -  Prior positive test for EGFR mutation or ALK gene rearrangement
  -  Uncontrolled tumor in the brain

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Genomic Landscape of Ceritinib

Summary: The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression.

Detailed description: Further improvements in therapy can only be achieved with a better understanding of the genomic landscape of ALK rearranged non-small cell lung cancer (NSCLC), specifically at the time of disease progression following treatment with ALK inhibitors. Recently, secondary ALK mutations, L1196M and G1269A have been described in patients with acquired resistance to crizotinib. A small subset of ALK positive lung cancer patients who progressed after treatment with ceritinib had tumors available for molecular analysis. Secondary mutations found included G1202R, F1174C, and F1174V. While this is interesting, an unbiased genomic study (exome or whole genome sequencing) using massively parallel sequencing at the time of disease progression is critical to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. To the best of the investigators' knowledge, such a study has not yet been reported.
  The investigators believe the time is ripe now to comprehensively characterize genomic alterations using massively parallel sequencing technology of ALK driven adenocarcinoma of the lung to fully understand the clonal heterogeneity before therapy and fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. A better understanding of genomic alterations through an unbiased comprehensive approach likely would lead to rationally designed therapy to augment response to ALK inhibitors.

Eligibility: Inclusion Criteria
  -  Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma.
  -  Presence of known ALK gene rearrangement.
  -  Consented to HRPO# 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma") with an existing specimen prior to initiation of treatment with ceritinib.
  -  At least 18 years of age.
  -  Received treatment with standard of care ceritinib

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

Summary: This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed extensive-stage SCLC
  -  Disease control after the first line platinum/etoposide treatment
  -  ECOG performance status of 0 or 1
  -  Measurable disease according to RECIST Version 1.1 criteria
  -  Adequate bone marrow, liver, and renal function.
  -  Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available.
  -  Resolution of any toxic effects of prior therapy according to NCI CTCAE, v 4.0
  -  Full recovery from significant complications of the surgery
  -  If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy
  -  Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential
  -  Signed informed consent prior to beginning protocol specific procedures
  -  Patients must be available for treatment and follow-up
  Exclusion Criteria:
  -  Previous therapies with Tivantinib or other known c-MET inhibitor
  -  Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study
  -  Palliative radiotherapy within 2 weeks prior to the inclusion in the study
  -  History of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen <0.2 ng / mL
  -  History of cardiac disease
  -  Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections
  -  Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception
  -  Need for breastfeeding during or within 12 weeks of completion of the study
  -  Gastrointestinal disorders that may interfere with the absorption of Tivantinib
  -  Inability or unwillingness to swallow the complete doses of Tivantinib
  -  Any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Summary: Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.


Eligibility: Inclusion criteria:
  -Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).
  First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.
  -  ECOG inferior or equal to 1 at screening.
  -  Further inclusion criteria apply
  Exclusion criteria:
  -  Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
  -  Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
  -  Further exclusion criteria apply.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Summary: Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

Detailed description: Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.
  Exclusion Criteria:
  -  ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Retrospective Epidemiological Study of Lung Cancer With Low-dose Multislice Computed Tomography

Summary: Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiology data for LDCT screening in Taiwan is lacking.
  National Taiwan University Hospital Chu-Tung Branch (NTUHCT) initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is establishing local epidemiological result via telephone follow-up and patients' medical records retrospectively.

Detailed description: Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiology data for LDCT screening in Taiwan is lacking.
  National Taiwan University Hospital Chu-Tung Branch (NTUHCT) initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is establishing local epidemiological result via telephone follow-up and patients' medical records retrospectively.
  Aim: To establish the local epidemiological data for lung pathology, emphysema, bronchiectasis and other lung disease.
  Methods: Since June 2015, more than 6000 LDCT were done at the NTUHCT. Roughly 6 months after the test telephone follow-ups about patient satisfactions, self-awareness of CT results, medical consultations and other related behaviors, and willingness of coming back for another test were routinely done. Retrospective secondary data analysis will be performed on the telephone follow-up results to establish local epidemiology data on lung pathology as well as information on screening accuracy of LDCT. Customers are also queried about willingness to provide their medical records, and linkage to National Health Insurance Database with informed consents to provide more advanced information on their long-term outcomes.
  Keywords: Lung cancer, Low dose computed tomography, screening.

Eligibility: Inclusion Criteria:
  -  self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

Summary: This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.


Eligibility: Inclusion Criteria:
  1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
  2. Positive EGFR mutation(19 exon or 21 exon)。
  Exclusion Criteria:
  1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  3. Allergic to icotinib
  4. metastases of spinal cord, meninges or meningeal.

Relevance to patient case: not relevant