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

Clinical trial: Study on Fluids Associated to Lung Cancer

Summary: The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).
  This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.
  The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.


Eligibility: Inclusion Criterias :
  -  Patients with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1).
  -  Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2).
  -  Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3).
  -  Adults patients : over 18 years.
  -  Persons affiliated to national social security.
  -  Free signed consent.
  Exclusion Criterias :
  -  Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.

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

Clinical trial: Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

Summary: The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

Detailed description: This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.
  Exclusion Criteria:
  -  Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.

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

Clinical trial: RCT Comparing 19Ga vs 22Ga EBUS-TBNA Needles in Carcinoma.

Summary: EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

Detailed description: All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

Eligibility: Inclusion Criteria:
  -  (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
  -  requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis
  Exclusion Criteria:
  -  uncontrolled coagulopathy
  -  tracheal stenosis

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

Clinical trial: Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

Summary: This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation


Eligibility: Inclusion Criteria:
  -  Patients with stage IIIB/IV non-small cell lung cancer
  -  Patients with uncommon epidermal growth factor receptor (EGFR) mutation
  -  Targeted-therapy-naive patients
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  -  Evaluable target lesions according to RECIST 1.1 for tumour response assessment
  Exclusion Criteria:
  -  Wild-type EGFR
  -  Positive 19 del and/or 21 L858R mutation
  -  Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
  -  Patients who have documented history of interstitial lung disease

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

Clinical trial: Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

Summary: Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Detailed description: For adenocarcinoma patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Eligibility: Inclusion Criteria:
  -  Suspected lung cancer before surgery
  -  No malignant tumor history within the past 5 years
  -  The pulmonary nodule is not pure ground glass opacity
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Multiple primary lung cancer
  -  R1,R2 resection
  -  Histology confirmed not non-small cell lung cancer
  -  Unqualified blood samples

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

Clinical trial: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma positive EBUS-TBNA specimen
  Exclusion Criteria:
  -  other diagnosis

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

Clinical trial: Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

Summary: In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

Detailed description: This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.
  The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.

Eligibility: Inclusion Criteria:
  1. lung adenocarcinoma, stage IV
  2. Patients with HER2 mutation by sequencing
  - Confirmed triple-negative patients with remnant tumor DNA
  3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
  4. ECOG performance status 0~2
  5. Patient with at least one measurable lesions according to RECIST
  6. Patients who have proper organ functions as follows
  -  Neutrophil count: > 1,500/uL
  -  Platelet count: > 100,000/uL
  -  Hb: > 9.0g/dL
  -  AST/ALT : < 2.0 x upper normal limit
  -  Bilirubin: < 1.25 x upper normal limit
  -  Serum creatinine : < upper normal limit
  Exclusion Criteria:
  1. Expected lie expectancy < 3 months
  2. CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
  3. Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  4. Patients who have histories of previous exposure to EGFR-TKI

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

Clinical trial: cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China

Summary: The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.

Detailed description: In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion

Eligibility: Inclusion Criteria:
  -  NSCLC adenocarcinoma patients confirmed by pathologist
  -  Initial, non-operative patients with stage III & IV adenocarcinoma
  -  Older than 18 years old
  -  Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.
  PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;
  -  Have a clear measurable tumor lesion in lung,under RIEST.
  -  Without severe drug allergy
  -  Patients participate in this trail must sign the informed consent
  Exclusion Criteria:
  -  Patients with brain metases related syndrome
  -  Patients with bone metases related complication
  -  Patients with cognitive disorder
  -  Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
  -  Patients with other severe complication and excluded by the researcher.
  -  Patients who are allergy with the TKI in this trail.
  -  Patients who participated in other trails or with anti-tumor treatments
  -  Patients who receive radiotherapy at the site of curative effect observation
  -  Patients who receive allogenic blood transfusion within 14 days

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

Clinical trial: Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Summary: The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

Detailed description: The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.

Eligibility: Inclusion Criteria:
  -  Individuals who have been diagnosed with lung cancer (survivor) or
  -  Caregiver of a participating lung cancer survivor
  -  Ability to read and write in English
  Exclusion Criteria:
  -  Individuals with significant psychiatric disturbance that requires a higher level of care
  -  Individuals with substance abuse/dependence problem that require a higher level of care
  -  Incarcerate individuals or individuals detained within the legal system

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

Clinical trial: Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection

Summary: Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does not require additional procedures but rather uses surplus, or leftover tumor specimens for molecular profiling.

Detailed description: The Strata Trial is a precision oncology collaboration structured as an observational master screening protocol with the aim to match patients to genomically-guided therapeutic protocols and/or approved therapies. Subjects enrolled on the Strata trial will submit surplus, clinical formalin fixed paraffin-embedded (FFPE) tumor specimens for molecular profiling and a test report will be provided back to the investigator. For those subjects identified as having molecular variants associated with an affiliated therapeutic protocol and/or approved targeted therapy, the Strata report will provide additional relevant information.
  All molecular profiling will be performed in the Strata Oncology CLIA-certified laboratory (Ann Arbor, MI). The molecular profiling assays will include targeted next generation sequencing (NGS) of DNA and RNA covering a range of actionable genomic variants, such as gene mutations (e.g. those in EGFR and BRAF), gene amplifications (e.g. ERBB2) and gene fusions (e.g. ALK).
  Subjects who have been identified with genetic alterations relevant to a trial or targeted therapy will be followed for treatment changes for three years from the time of signed informed consent.

Eligibility: Inclusion Criteria:
  -  Subjects must be ≥ 18 years of age.
  -  Subjects must have histologically documented solid tumors or lymphoma.
  -  Subjects must have measurable (>10mm lesion) metastatic disease (i.e. Stage IV) or unresectable disease (e.g. glioblastoma, Stage III pancreatic cancer)
  -  Subjects must have ECOG performance status ≤ 2, see Appendix I.
  -  Subjects must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.

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

Clinical trial: Circulating Tumor DNA in Surgical Lung Cancer Patients

Summary: Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Detailed description: Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.
  The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility: Inclusion Criteria:
  Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent
  Exclusion Criteria:
  Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples

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

Clinical trial: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Summary: Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.

Detailed description: Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.

Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Social security affiliation
  -  Written informed consent
  -  Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
  -  D-dimer > 1,500 µg/L
  -  Planned or ongoing chemotherapy or targeted anticancer therapy
  -  ECOG 0-2
  -  Life expectancy >3 months
  Exclusion Criteria:
  -  Hypersensitivity to heparin
  -  History of heparin-induced thrombocytopenia
  -  Ongoing anticoagulant treatment
  -  VTE at inclusion
  -  Creatinin clearance <30 mL/min
  -  Active bleeding
  -  Platelet count < 100,000 G/L at inclusion
  -  Severe hepatic insufficiency
  -  Cancer treated exclusively with supportive care
  -  Previous inclusion in the trial
  -  Aspirin at daily dosage > 160 mg
  -  Pregnancy

Relevance to patient case: not relevant