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

Clinical trial: Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.
  PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage III non-small cell lung cancer and have no CNS metastatic disease.
  OUTLINE: This is a pilot, nonrandomized study.
  Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for analysis.
  After completion of study, patients will be monitored for 1 month after LP to assess for any LP-related complications.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D.
  -  Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week
  -  No known CNS primary or metastatic cancer at any time prior to time of enrollment
  -  No MRI evidence of pathological enhancement at the time of study entry
  PATIENT CHARACTERISTICS:
  -  Patients must use adequate birth control measures while in the study
  -  No significant side effects to erlotinib that require dose reduction or interruption
  -  None of the following medical issues which could make a lumbar puncture unsafe:
  -  Platelets < 100,000/mm³
  -  INR > 1.1
  -  Known bleeding dyscrasia
  -  Absolute neutrophil count < 1,500/mm³
  -  Ongoing systemic bacterial infection
  PRIOR CONCURRENT THERAPY:
  -  Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following:
  -  Neurontin
  -  Lamictal
  -  Depakote, Depakene
  -  Felbatol
  -  Keppra
  -  Gabitril
  -  Topimax
  -  Zonegran
  -  No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital
  -  No concurrent other drug known to affect the metabolism of erlotinib
  -  No concurrent anticoagulant therapy

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

Clinical trial: Removal of Lung Nodules After Being Marked With a Microcoil

Summary: The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
  The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.

Detailed description: Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.

Eligibility: Inclusion Criteria:
  -  subcentimetre lung nodule
  Exclusion Criteria:

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

Clinical trial: First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Summary: The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.


Eligibility: Inclusion Criteria:
  -  Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
  -  WHO Performance Status 0-2
  -  No prior chemotherapy, biological or immunological therapy/surgery
  Exclusion Criteria:
  -  Any evidence of clinically active interstitial lung disease
  -  Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
  -  Patients with previously diagnosed and treated CNS metastases or spinal cord compression

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 of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

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

Clinical trial: Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Summary: The goals of this study are:
  -  to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
  -  to assess response to treatment in patients with NSCLC six months after beginning study treatment.


Eligibility: Inclusion Criteria:
  -  18 years or older
  -  Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
  -  ECOG performance status score of 0 or 1
  Exclusion Criteria:
  -  Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
  -  Symptomatic or uncontrolled brain metastases
  -  Evidence of meningeal metastasis
  -  > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
  -  Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments

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

Clinical trial: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

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

Clinical trial: Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy

Summary: The purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.

Detailed description: This study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. DNA will be extracted from patients' peripheral blood to study SNPs in DPD, TS, MTHFR, UGT1A1, CYP3A4, CYP3A5, GSTM1, GSTT1, GSTP1, HO-1, ERCC1, XPD, XRCC1 and EGFR genes. The results of genetic study will be compared to treatment efficacy and toxicity. The ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity.

Eligibility: Inclusion Criteria:
  -  Lung, Colorectal and Head and Neck Cancer Patients that have received or plan to receive chemotherapy as part of their treatment
  Exclusion Criteria:
  -  Colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy
  -  Head and Neck cancer patients that have never received or will not receive chemotherapy as part of their treatment
  -  Patients with cancer types other than colorectal or head and neck
  -  Unable to give informed consent

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

Clinical trial: Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

Summary: RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.
  PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed description: OBJECTIVES:
  -  Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.
  OUTLINE: This is a prospective study.
  Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Any disease stage allowed
  -  Undergoing targeted treatment
  Exclusion Criteria:

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

Clinical trial: DNA Analysis of Blood and Tissue From Patients With Lung Cancer

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
  PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Detailed description: OBJECTIVES:
  -  Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
  -  Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
  -  Assess the roles of gender and age in the genetic susceptibility of lung cancer.
  -  Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
  -  Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
  -  Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.
  OUTLINE: This is a case-control study.
  Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.
  Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.
  PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patient:
  -  Newly diagnosed lung cancer
  -  Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center
  -  Control:
  -  Nonblood-related friend or spouse of the patient
  -  No specific matching characteristics
  -  Friend or spouse of other hospital patients
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified
  EXCLUSIONS:
  Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded

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 of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer

Summary: RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients.
  PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
  -  Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
  -  Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
  -  Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.
  OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing [surgery] vs less impairing [chemotherapy/radiotherapy]).
  Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).
  Cancer treatment and medical history information are gathered from patients' medical records.

Eligibility: PATIENT CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Head and neck cancer
  -  Lung cancer (control group)
  -  Must have received treatment for head and neck cancer or lung cancer within the past 5 years
  PATIENT CHARACTERISTICS:
  -  Able to speak and read English to answer surveys, interviews, and questionnaires
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Gene Polymorphisms and Symptoms in Lung Cancer Patients

Summary: Primary Objectives:
  -  Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.
  -  Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.
  Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
  This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.

Detailed description: If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning).
  You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time.
  You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time.
  Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study.
  This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  -  Patient has lung cancer and is being treated at M. D. Anderson.
  -  At least 18 years of age
  -  Currently living in the United States
  -  Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
  -  English or Spanish speaking
  Exclusion Criteria:
  -  Patient is unable to understand the intent of the study.

Relevance to patient case: not relevant