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

Clinical trial: Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Summary: In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.
  There is two types of maintenance strategies:
  -  Continuous maintenance : prolongation of the treatment initially associated with platin until progression
  -  Switch maintenance : introduction of a new treatment after the end of induction chemotherapy
  The aim of this study is to compare two maintenance strategies
  -  A continuous maintenance by pemetrexed
  -  A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.


Eligibility: Inclusion Criteria:
  -  Non-squamous NSCLC histologically or cytologically confirmed
  -  Stage IV with a cytologically or histologically confirmation for an unique metastasis
  -  No EGFR activating mutation or indeterminate EGFR mutational status
  -  At least one measurable lesion
  -  Age between 18 and 70
  -  PS 0 or 1
  Exclusion Criteria:
  -  squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
  -  Knowledge of ALK gene rearrangement
  -  Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
  -  Superior venous cave syndrome except if treated by implantation of a prosthesis
  -  Previous anti-tumoral treatment
  -  Concomitant radiotherapy

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

Clinical trial: An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

Summary: The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.
  The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.


Eligibility: Inclusion Criteria:
  1. Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
  2. Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
  • Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
  Or:
  • Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
  3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
  4. Patients must have received prior platinum containing treatment.
  5. WHO performance status of 0-1
  Exclusion Criteria:
  1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
  2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
  3. Prior treatment with an HSP90 inhibitor

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

Clinical trial: Chest Imaging, Breath, and Biomarkers in a Screening Trial

Summary: The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.

Detailed description: The fight against lung cancer is waged on three major fronts: prevention, detection and treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective. If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.

Eligibility: Inclusion Criteria:
  -  ages 40-75 years
  -  If ages 40-59, then one of the following criteria needs to be met:
  -  Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR
  -  current or ex-smoker with > 25 pack years and COPD OR
  -  current or ex-smoker with a > 35 pack year history
  -  If ages 60-75, then one of the following additional criteria needs to be met:
  -  Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR
  -  Current or ex-smoker with >25 pack years and COPD OR
  -  Current or ex-smoker with a >30 pack year history
  -  Subject is able to return to Cleveland Clinic for annual follow-up screening
  -  Subject is willing to sign a medical release form
  Exclusion Criteria:
  -  Current health requires oxygen
  -  Have had a chest x-ray or CT of the chest within the last 6 months
  -  Previous pneumonectomy
  -  Lobectomy of the lung within the last 5 years
  -  Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer
  -  A medical condition that would prevent treatment for lung cancer
  -  Within the last 6 weeks, one of the following has occured:
  -  A new cough or chronic cough that has gotten worse
  -  Either new shortness of breath, or any worsening of shortness of breath
  -  A cough producing blood
  -  Constant chest pain
  -  Respiratory infection, pneumonia, or cold
  -  Unintentional and unexplained weight loss greater than 5% of total body weight

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

Clinical trial: Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Summary: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed description: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
  Primary endpoint:
  Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
  Secondary endpoint:
  1. Overall survival between icotinib and chemotherapy
  2. Time to Progression between icotinib and chemotherapy
  3. Objective response rate and disease control rate between icotinib and chemotherapy

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).
  Exclusion Criteria:
  -  Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

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

Clinical trial: Free Fatty Acid Metabolite Biomarkers for Cancer

Summary: Surgical removal of tumor at an early stage remains the primary treatment for most cancers. However, there is currently no reliable screening blood test for detection of lung, colon, or breast cancer. The Specific Aims are to: 1) assess the diagnostic accuracy of six FFA metabolites to detect lung and colon cancer in surgical patients; 2)determine the rate and extent to which FFA metabolites decrease over time after surgery for lung and colon cancer; and, 3)determine the positive and negative predictive values and overall test accuracy for diagnostic prostate and breast biopsies.


Eligibility: Inclusion Criteria:
  -  potential breast cancer
  -  patients who have early stages of breast cancer prior to surgery potential prostate cancer lung cancer colon cancer
  Exclusion Criteria:
  -  1) Patients will be excluded from enrollment if they have severe liver disease (ALT three times the upper limit of normal). Patients will also be excluded who have taken aspirin or COX inhibitors within 48 hours of surgery. 2) Patients will be excluded if a pathologic diagnosis is already available,from a previous needle biopsy (coordinator will remain blinded). 3) Patients will be excluded have received pre-procedure chemotherapy or radiotherapy

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

Clinical trial: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

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

Clinical trial: Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

Summary: At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
  In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
  The question is to know if this strategy is feasible in lung cancer.


Eligibility: Inclusion Criteria:
  -  Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
  -  Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
  -  Measurable disease (recist criteria)
  -  Age ≥18 years
  -  PS0 or 1
  Exclusion Criteria:
  -  Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
  -  History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
  -  Tumor invaded the big vessels or the proximal visible in TDM.
  -  History of adjuvant or neoadjuvant chemotherapy

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

Clinical trial: Mechanisms of Immunosurveillance for Lung Cancer

Summary: The purpose of this research study is to investigate the differences in "natural killer (NK) blood cells, a type of white blood cell that fights infection in the body, among different types of patients that have lung surgery. The four different groups of patients are:
  -  smokers with lung cancer
  -  smokers without lung cancer
  -  non-smokers with lung cancer
  -  non-smokers without lung cancer.

Detailed description: Research has shown that different strains of mice possess varying susceptibility to lung cancer. C3H and C57BL6 mice are highly resistant to lung cancer, whereas A/J and 129 mice are very susceptible to lung cancer. Data from our lab shows that the mice have different numbers of natural killer (NK) cells as well as different characteristics of those cells. C3H and C57BL6 mice have higher numbers of NK cells as well as higher expression of CD11b, whereas A/J and 129 mice have lower numbers and lower expression.
  These findings justify parallel investigation of NK cells in human populations resistant and susceptible to lung cancer. Through blood samples, circulating NK cells can be counted and phenotypically analyzed. Smoking can be used as a factor to establish lung cancer risk. Additionally, non-smokers suffering from lung cancer provide an opportunity to investigate whether lung cancer patients have lower abundance of NK cells and lesser expression of CD11b, independent of the effects of smoking.
  Objective:
  The main goal of this study is to investigate the quantitative and phenotypic differences in circulating NK cells among human populations. Participants will be classified as heavy smokers (HS), non-smokers (NS), those suffering from lung cancer (LC), and those free from lung cancer (NC).
  Hypothesis #1: NS/LC participants will have fewer NK cells and lower expression of CD11b compared to HS/NC and NS/NC participants.
  Hypothesis #2: NS/LC participants will have more numerous NK cells and higher expression of CD11b compared to HS/LC participants.

Eligibility: Inclusion Criteria:
  -  Age equal or greater to 18 years
  -  Ability to read and write in English
  -  Able to participate in the informed consent process
  Exclusion Criteria:
  -  Known active hepatitis B, hepatitis C, or HIV/AIDs (found in medical record)
  -  Chemotherapy or radiation therapy within 3 months of enrollment
  -  Type 1 Diabetes Mellitus
  -  Rheumatoid arthritis, Lupus, Multiple Sclerosis, or any other autoimmune disease as deemed necessary for exclusion by the Principal Investigator
  -  Previous organ transplant
  -  Blood transfusion within 3 months prior to enrollment
  -  Any previous cancer, excluding a previous lung cancer
  -  Steroid use within 4 weeks of enrollment

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

Clinical trial: Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients

Summary: The purpose of this study is to evaluate the effect of supervised physical exercise on endothelial function and number of endothelial progenitor cells (EPCs) in patients with systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise on endothelium derived growth factor (VEGF) levels, disease activity, quality of life, fatigue, perceived exertion and cardiopulmonary exercise test variables.

Detailed description: Several studies have shown that cardiovascular morbimortality is more frequent and early in SLE patients than in the general population and cardiovascular disease is an important cause of morbidity and mortality in systemic lupus erythematosus patients. Disturbances in endothelial function are implicated in its pathogenesis. Endothelial function also depends on endothelial progenitor cells (EPCs) that enhance angiogenesis, promote vascular repair and have potential as a marker of cardiovascular disease. Systemic lupus erythematosus patients have endothelial dysfunction and fewer EPCs. There are studies showing improvement of endothelial function and EPCs after physical exercise program in individuals with heart failure, diabetes and coronary arterial disease, but there isn't studies evaluating endothelial function and EPCs after.

Eligibility: Inclusion Criteria:
  -  female systemic lupus erythematosus patients
  -  18 to 45 years of age
  -  Fulfilled at least four criteria classification for lupus (ACR criteria, 1997) - Signed the consent form approved by the ethics committee of the institution
  Exclusion Criteria:
  -  Hemoglobin < 10 mg/dL
  -  Neuropsychiatric, pulmonary, articular or vascular damage that would prevent the practice of exercise
  -  Coronary disease or heart failure, functional class ≥ II
  -  Pulmonary hypertension
  -  Uncontrolled hypertension
  -  Creatinine ≥ 1.4 mg/dL
  -  Body mass index (BMI) ≥ 35 kg/m2
  -  Diabetes mellitus
  -  Uncontrolled hypothyroidism
  -  Smoking in the last 12 months
  -  Pregnancy
  -  Menopause
  -  Use of statins in the last three months
  -  Practice of physical exercise in past three months
  -  Overlap with other autoimmune rheumatic diseases, except antiphospholipid syndrome.

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

Clinical trial: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility: Inclusion Criteria:
  -  NSCLC confirmed by histopathology or cytology;
  -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
  -  Has active mutation of EGFR in exon 19 or 21;
  -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  -  expectancy life >= 12 weeks;
  Exclusion Criteria:
  -  Had be treated by HER-targeting agents;
  -  Had systemic anit-NSCLC treatments;
  -  Had local radiotherapy for NSCLC;
  -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
  -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

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

Clinical trial: Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

Summary: The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.


Eligibility: Inclusion Criteria:
  Inclusion Criteria for patients´ screening:
  -  Patients of both sexes aged 18 or more.
  -  Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
  -  Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
  -  Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
  -  Patients who have granted their written informed consent.
  Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
  Inclusion Criteria for patients´ follow-up
  -  Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
  Exclusion Criteria:
  -  Combined histology of non-small cell and small cell lung cancer.

Relevance to patient case: definitely relevant