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

Clinical trial: A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
  -  Patients who take EGFR-TKI as first/second line therapy.
  Exclusion Criteria:
  -  Patients who has taken EGFR-TKI before.
  -  Patients who take EGFR-TKI as third or more line.
  -  Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
  -  The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
  -  Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

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

Clinical trial: Radiofrequency Ablation of Malignant Pulmonary Nodules

Summary: The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.

Detailed description: Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed malignant pulmonary nodules.
  2. Patients refuse or are not suitable for surgical resections.
  3. 1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
  4. Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.
  Exclusion Criteria:
  1. Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
  2. With extensive extrapulmonary or intrapulmonary metastasis.
  3. Have taken anticoagulant as aspirin in one week.
  4. Target nodules nearby pleura or other important hilum and mediastinum structures.
  5. With metal implants are adjacent to the target tissues which will be covered with ablation area.

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

Clinical trial: CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy

Summary: This pilot clinical trial studies computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To assess the feasibility of performing perfusion CT imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care.
  SECONDARY OBJECTIVES:
  I. To determine the range (variability) of perfusion parameters, including blood flow, blood volume, transit time, and permeability at each time point.
  II. To assess the change in perfusion parameters between these time points. III. To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at these time points.
  IV. To correlate perfusion parameters with tumor response 1 year post-SABR.
  OUTLINE:
  Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR.
  After completion of treatment, patients are followed up at 2-4 months and then at 1 year.

Eligibility: Inclusion Criteria:
  -  Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
  Exclusion Criteria:
  -  Patients who are pregnant or are trying to become pregnant are excluded from this study
  -  Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded

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

Clinical trial: An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

Summary: This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will further evaluate the recommended dose determined in Part 1 in subjects with select tumor types.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
  -  Part 1: Subjects with advanced or metastatic solid tumors
  -  Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma
  -  Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or subjects who refuse standard treatment
  -  Presence of measureable disease based on RECIST v1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  Exclusion Criteria:
  -  Laboratory and medical history parameters not within the protocol-defined range
  -  Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
  -  Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy
  -  Receipt of a live vaccine within 30 days of planned start of study therapy
  -  Active autoimmune disease that required systemic treatment in the past 2 years

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

Clinical trial: In Vivo EGFR Molecular Classification

Summary: The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.

Detailed description: The goal of investigators were to evaluate the use of 18F-MPG as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-MPG in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.

Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  18 years or older
  -  A life expectancy of at least 12 weeks
  -  Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
  -  Written informed consent
  Exclusion Criteria:
  -  Claustrophobia
  -  Pregnancy
  -  Metal implants in the thorax

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

Clinical trial: The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

Summary: To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Detailed description: Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.
  Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.
  Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Eligibility: Inclusion Criteria:
  -  NSCLC based on histopathologic examination
  -  Adenocarcinoma and/or nonadenocarcinoma based on histology examination
  -  Clinical stadium stage IIIB and IV
  -  Age 16-70 years old
  -  Received gefitinib as therapy
  -  At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015
  Exclusion Criteria:
  -  Missing data of any variables of the treatment outcomes in the medical record

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

Clinical trial: Perfusion CT Imaging in Lung Cancer With SBRT

Summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility: Inclusion Criteria:
  -  Gender: male or female
  -  CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
  -  Patient will sign a consent form prior to study entry
  -  Lung cancer and lung metastases are biopsy proven
  Exclusion Criteria:
  -  Patients who are unable to give valid informed consent
  -  Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

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

Clinical trial: Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)

Summary: The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. The investigators will also determine the effect of allowing providers to design their own risk threshold algorithms into a lung cancer screening decision aid, Decision Precision. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

Detailed description: The overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the Decision Precision lung cancer screening tool. The investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. Secondly, the investigators will determine the effect on tool use of allowing providers to design their own risk threshold algorithms by enrolling sites in a step wedge design into risk tailoring. Thirdly, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will have a human subjects research component to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

Eligibility: Inclusion Criteria:
  -  Patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period
  Exclusion Criteria:
  Exclusions for initial lung cancer screening clinical reminders:
  -  history of lung, pancreatic, liver or esophageal cancer
  -  a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest CT in the past 12 months

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

Clinical trial: Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

Summary: Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.
  This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
  Patients eligible for this study may have previously received treatment with a checkpoint inhibitor.

Detailed description: The treatment regimen will begin with a 7-Day Lead-in Period of mocetinostat alone followed by start of the combination regimen of mocetinostat and durvalumab. The Recommended Phase 2 Dose of mocetinostat will be established in the Phase 1 dose escalation segment, followed by evaluation of the clinical activity of the combination regimen in Phase 2.

Eligibility: Inclusion Criteria:
  -  Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
  -  Not amenable to treatment with curative intent
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  Impaired heart function
  -  Uncontrolled tumor in the brain
  -  Other active cancer

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

Clinical trial: Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

Summary: This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.


Eligibility: Inclusion Criteria:
  -  patients with advanced nonsmall-cell lung cancer
  -  known HER2 exon-20 insertion
  -  treated with chemotherapy and/or HER2-targeted drugs
  Exclusion Criteria:

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

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: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

Summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility: Inclusion Criteria
  Patient:
  -  Men aged 20 to 65 years
  -  Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
  -  With an AHI > 5 / h
  Healthy volunteers:
  -  Men aged 20 to 65 years
  -  With an AHI ≤ 5 / h
  Exclusion Criteria
  All subjects:
  -  Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
  -  Known cardiovascular disease associated (heart failure, rhythm disorder ...)
  -  Known respiratory diseases
  -  Known neoplastic pathology, known chronic inflammatory disease
  -  Psychiatric pathology treated
  -  Medication
  -  Not affiliated to the French social health care system
  -  Major protected person
  -  Private person of liberty
  -  People in emergency situation
  -  Patient refusing to participate in the study

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

Clinical trial: Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery for Recurrent Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Detailed description: Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
  In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility: Inclusion Criteria:
  -  Age ≤ 75 years with histologically proven NSCLC
  -  No severe major organ dysfunction
  -  WHO performance status of 0 or 1
  -  No prior cancer chemotherapy
  -  A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
  Exclusion Criteria:
  -  Age ≥ 76
  -  Severe major organ dysfunction
  -  WHO performance status of >1
  -  Prior cancer chemotherapy
  -  Stage IV

Relevance to patient case: not relevant