araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

Summary: Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.

Detailed description: Prospective and multicenter study conducted in the Rhône-Alpes-Auvergne area. All patients suffering from lung cancer admitted to a pulmonology unit in 2014 will be included. This document will be used if a decision to withhold life-sustaining treatment is decided. Investigators will assess the relationship between the planned intensity of care and those established when the patient develops an organ failure. Patient characteristics and factors associated with proposed levels and types of care will be analyzed. Patient and family opinions will be obtained after 3 months. The number of subjects is 468.

Eligibility: Inclusion Criteria:
  -  Any patient with lung cancer, hospitalized in pulmonology unit in one of the participating centers.
  -  Patient who requires a decision to withhold life-sustaining treatment
  -  One patient can be included at each hospitalization.
  Exclusion Criteria:
  -  Minor patient
  -  Refusal of participation of the patient in the study

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Summary: The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

Detailed description: This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).
  Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
  The endpoint of this study included clinical efficacy and safety.

Eligibility: Inclusion Criteria:
  -  Stage Ⅳ EGFR mutation-positive NSCLC
  -  Initial therapy
  -  ECOG performance status 0-1
  Exclusion Criteria:
  -  EGFR mutation-negative
  -  Previous systemic antitumour treatment

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule

Summary: The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.

Detailed description: The goals of investigators are to evaluate the use of [68Ga]-labelling Anti-EGFR Affibody Molecule as a novel PET/CT radiotracer to monitor EGFR-ECD expression status and classify EGFR-ECD benefit NSCLC patients. The investigators want to evaluated the use of [68Ga]-labelling Anti-EGFR Affibody Molecule in lung cancer imaging in adult NSCLC patients with different EGFR-ECD expression 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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

Summary: The purpose of this study is to determine the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Detailed description: A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Eligibility: Inclusion Criteria:
  -  Stage I-III Non-small cell lung cancer survivors
  -  Must be at >6-weeks and < 3 years post-surgical resection
  -  Must have diagnosis fatigue and/or sleep disturbances
  Exclusion Criteria:
  -  Individuals clinically unstable.
  -  Mania, Bipolar disease or seizure disorder
  -  Macular degeneration or glaucoma.
  -  Currently receiving chemotherapy or radiation.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Summary: Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility: Inclusion Criteria:
  -  local advanced or metastatic non-small cell lung cancer
  -  large cell lung carcinoma or adenocinoma
  -  Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
  -  EGFR T790M positive
  -  No uncontrolled hypertension
  -  No active bleeding or thrombosis in recent 6 months
  -  No previously treated with VEGF antibody
  Exclusion Criteria:
  -  newly diagnosed thrombosis
  -  anti-coagulation therapy
  -  uncontrolled hypertension
  -  uncontrolled nephropathy

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR TKI Therapy

Summary: A comparison of baseline tumor characteristics in EGFR mutant lung cancers to tumor characteristics after early response of EGFR-TKI targeted treatment to allow identification of early adaptive mechanisms of cell survival in the setting of oncogene-targeted therapy. This identification will facilitate targeting and termination of these survival/resistance pathways before they develop with rational combination of therapeutic agents to improve outcomes.


Eligibility: Inclusion Criteria:
  -  Carry a diagnosis of stage IV lung adenocarcinoma with an EGFR activating mutation
  -  Aged 18 - 85 years or older
  -  ECOG 0-2
  -  Have a histologically confirmed diagnosis of lung adenocarcinoma harboring an EGFR sensitizing mutation (including, but not limited to: G719X, del exon 19, or L858R).
  -  No prior therapy for metastatic disease.
  -  Planned treatment with a single agent EGFR TKI including but not limited to:
  1. erlotinib,
  2. gefitinib,
  3. rociletinib (CO-1686),
  4. afatinib, or
  5. osimertinib (AZD-9291).
  -  Patients must have at least one site of measurable disease ≥ least 2cm.
  -  Primary disease site or site of metastatic disease must be amenable to biopsy.
  -  Patients must have the ability to understand and willingness to sign an informed consent document.
  -  Patients must be willing to undergo an initial pre-treatment biopsy of tumor tissue (or have previously collected frozen tissue) and a follow-up biopsy 2 weeks (+/- 1 week) after treatment start
  Exclusion Criteria:
  -  Concurrent health problem which would preclude tissue biopsy (eg hemophilia or other bleeding predisposition).
  -  Patients whose only source of biopsiable disease is:
  1. intracranial,
  2. pleural effusion or any lesion that is deemed unsafe to biopsy by the treating physician or,
  3. interventional radiology.

Relevance to patient case: definitely relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Summary: The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Eligibility: Inclusion Criteria:
  -  Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC
  -  Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib.
  -  Any number of prior chemotherapy regimens is permitted.
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  KPS >/= 70%
  -  Age >18 years old
  -  Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of > 10 unstained slides)
  -  Left ventricular Ejection Fraction >/= the lower limit of normal by ECHO or MUGA
  -  Adequate organ function:
  -  AST, ALT </= 2.5 x ULN
  -  Total bilirubin </= 1.5 x ULN
  -  Albumin>/=2.6g/dL - Creatinine < 1.5 x ULN OR calculated creatinine clearance >/=50mL/min
  -  Absolute neutrophil count (ANC) >/= 1,200 cells/mm3
  -  Hemoglobin>/=9.0 g/dL
  -  Platelets >/=100,000/mm3
  Exclusion Criteria:
  -  Patients with symptomatic brain metastasis requiring escalating doses of steroids
  -  Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
  -  Pregnant or lactating women
  -  Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI
  -  Patients who have received prior treatment with a MEK inhibitor
  -  Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol.
  -  A history of clinically significant interstitial lung disease or pneumonitis
  -  Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval >480msec, treatment refractory hypertension, presence of a cardiac defibrillator
  -  History of central serous retinopathy or retinal vein occlusion

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients

Summary: The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients.
  Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is able to decrease viral load in the lungs, it should also be able to decrease lung-cell inflammation in these patients.

Detailed description: Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore reflect the viral load in the lung. If so, treatment that reduces viral load in the lung (e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the alveolar space and should return pulmonary immune responses toward normal.
  Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is performed and blood samples are collected prior to initiation of HAART and after 1 and 6 months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets. Responses in the lung are compared to simultaneous changes in these variables found in the peripheral blood. Each patient serves as his/her own control.

Eligibility: Inclusion Criteria
  Patients may be eligible for this study if they:
  -  Are HIV-positive.
  -  Are at least 18 years old.
  -  Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml.
  -  Are about to start a regimen of at least 3 anti-HIV drugs (HAART).
  Exclusion Criteria
  Patients will not be eligible for this study if they:
  -  Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
  -  Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath).
  -  Have received certain medications, including HIV vaccines.
  -  Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy.
  -  Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of the study.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer

Summary: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell lung cancer cells.
  PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and median duration of response of interleukin-2 (IL-2) in patients with previously treated non-small cell lung cancer. II. Determine the median survival of patients treated with IL-2. III. Further delineate the toxicity of IL-2 in these patients.
  OUTLINE: This is an open label study. Patients receive bolus interleukin-2 on days 1-5 and 8-12. The cycle repeats every 3 weeks. Patient response is evaluated after 2 cycles. Patients with stable disease, partial, or complete response may be treated with maintenance IL-2 for up to 4 additional cycles. Patient evaluation is performed after every 2 cycles. At this point, patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete response.
  PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-small cell lung cancer At least one prior systemic therapy OR prior radiation therapy Must have measurable disease Previously irradiated sites of disease are not considered evaluable unless there is radiologic documentation of progression
  PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No prior history of myocardial infarction within previous 6 months No uncompensated congestive heart failure No primary (not due to electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions Pulmonary: No dyspnea at rest or need for supplemental oxygen Patients with symptomatic lung disease or extensive lung metastases must have oxygen saturation greater than 90% Other: Not pregnant or nursing Negative pregnancy test Patients with elevated temperatures greater than 100.5 F must have no occult infection
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent cyclosporin Chemotherapy: At least 3 weeks since chemotherapy and recovered No concurrent methotrexate See Disease Characteristics Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since radiotherapy See Disease Characteristics Surgery: Not specified

Relevance to patient case: not relevant