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

Clinical trial: The Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis

Summary: The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Detailed description: Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility: Inclusion Criteria:
  1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
  2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
  Exclusion criteria:
  includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.

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

Clinical trial: A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

Summary: This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.


Eligibility: Inclusion Criteria:
  -  18 years old at time of consent
  -  Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
  -  EGFR-positive tumor expression
  -  Adequate blood and organ function
  -  Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
  -  Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements
  Exclusion Criteria:
  -  Other anti-cancer treatment during the study
  -  Symptomatic brain metastases
  -  Other clinically significant disease as defined by the protocol
  -  Chronic skin condition that requires prescribed oral or intravenous treatment
  -  History of severe rash that required discontinuation of prior EGFR targeted therapy
  -  Receiving therapeutic doses of warfarin or heparin for anti-coagulation
  -  Known diagnosis of HIV or active viral hepatitis
  -  Women who are pregnant or breast feeding

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

Clinical trial: Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer

Summary: The purpose of this study is to test the safety of different ways of taking erlotinib. The investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are also seeing whether different schedules of erlotinib are better at treating lung cancer that has spread to the central nervous system.
  CNS expansion phase:
  The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the expansion cohorts will undergo the same treatment plan as the patients in the dose expansion cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the first 28 day (cycle 1) treatment period.


Eligibility: Inclusion Criteria:
  -  MSKCC pathologically-proven diagnosis locally advanced Stage III not amenable to definitive, curative treatment or Stage IV or recurrent non-small cell lung cancer
  -  Documented presence of EGFR mutation confirmed by MSKCC or a local facility.
  -  No prior treatment with erlotinib, gefitinib, or other EGFR tyrosine kinase inhibitors
  -  Age ≥ 18 years
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated.
  -  Karnofsky Performance Status ≥ 70%
  -  Ability to take oral medications
  -  A negative serum pregnancy test obtained within 4 weeks prior to the start of treatment in all women of child-bearing potential.
  -  All women of child bearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, Depo-Provera, permanent sterilization of patient or partner or total abstinence.
  Expansion A:
  -  brain metastases or leptomeningeal not previously treated with radiation or surgery
  Exclusion Criteria:
  -  Inadequate recovery from any toxicity related to prior treatment (to Grade 2 or baseline).
  -  Inadequate hematologic function defined as ANC < 1000 cells/mm³, Platelet count <75,000/mm³ or Hemoglobin <9.0g/dL.
  -  Inadequate hepatic function defined by AST/ALT >3x upper limit of normal (ULN), Total bilirubin>2x ULN, Alkaline phosphatase >3x ULN.
  -  Symptomatic brain metastasis requiring radiation therapy or escalating doses of steroids.
  -  Patients with clinically stable brain metastases or leptomeningeal disease (previously treated or untreated) are eligible. Patients in expansion cohort A must have at least one untreated CNS lesion
  -  Women who are breastfeeding or pregnant.
  -  Any evidence of clinically active interstitial lung disease.

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

Clinical trial: A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in Non-small Cell Lung Cancer(NSCLC)Treatment

Summary: For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

Detailed description: The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

Eligibility: Inclusion Criteria:
  The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:
  uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

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

Clinical trial: Circulating Fibrocytes in Non-small Cell Lung Cancer.

Summary: The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Detailed description: Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  Exclusion Criteria:
  -  Combination of other malignancy.
  -  Age less than 20 years (not include 20 years).
  -  Pregnancy.

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

Clinical trial: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Detailed description: Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included.
  The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility: Inclusion Criteria:
  -  lung cancer
  -  Organ failure
  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: A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

Summary: The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.

Detailed description: This is a Phase 0 multi-center and longitudinal study of biomarkers and clinical parameters in patients with lupus erythematosus (LE). Approximately 80 participants (20 healthy participants and 60 patients with LE) will be enrolled. This will include 30 with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE), and 30 with DLE/SCLE with SLE. All patients with LE will continue to be managed by their personal physicians per their standard-of-care. Study participants will undergo interventional procedures that include collection of urine, blood samples and skin biopsy. There will be a single sample collection timepoint for healthy participants and two sample collection timepoints for LE patients, separated by approximately 12 weeks. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. The data obtained in this study will be used in the evaluation of new therapies for lupus and may help in developing new treatments. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examinations. The total duration of study participation will be approximately 11 days for healthy participants and 95 days for patients with LE.

Eligibility: Inclusion Criteria:
  -  Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
  -  Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
  -  Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
  -  An active skin lesion that can be biopsied (for participants with lupus erythematosus)
  Exclusion Criteria:
  -  Known or thought to have a diagnosis of drug-induced lupus
  -  An active skin disease that is not a manifestation of lupus erythematosus
  -  Has an acute cutaneous lupus erythematosus rash only
  -  If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
  -  Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
  -  Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus

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

Clinical trial: Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

Summary: Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Detailed description: Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.
  Methods:
  A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

Eligibility: Inclusion Criteria:
  1. Diagnose malignant pleural effusions by:
  -  Diagnose malignant pleural neoplasms by histopathology
  -  Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
  2. Written informed consent
  Exclusion Criteria:
  1. <18years of age
  2. Expected survival <3 months
  3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
  4. Planned chemotherapy
  5. Pregnancy or breast-feeding (women of child-bearing potential)
  6. Not signed informed consent or non-compliance with treatment protocols

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

Clinical trial: Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Summary: The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.

Detailed description: A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC.
  -  Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
  -  Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
  -  Performance status: WHO 0-2
  -  Measurable disease according to RECIST 1.1
  -  Patients must be able to comply with study treatments
  -  Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
  -  Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
  -  Patient must be able to comply with the protocol
  Exclusion Criteria:
  -  RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
  -  Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
  -  Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
  -  Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
  -  Patient with symptomatic central nervous system metastases
  -  Patient has known active hepatitis B or C, or HIV infection
  -  Pregnant or breastfeeding.
  -  Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

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

Clinical trial: Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient

Summary: In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.
  This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.
  Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.
  To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.
  The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.
  A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.
  The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.


Eligibility: Inclusion Criteria:
  -  age over superior to 18
  -  NSCLC proved by a histological biopsy
  -  EGFR mutation status known with no activating EGFR mutation
  -  indication of erlotinib therapy after at least one previous therapy
  -  patients who have signed an informed consent to participate in this study
  -  life expectancy exceeding 12 weeks
  -  WHO activity score between 0 and 2.
  Exclusion Criteria:
  -  contraindication for the initiation of erlotinib
  -  refusal to sign the consent
  -  progressive inflammatory disease
  -  infection with the HIV virus
  -  other malignant disease
  -  life expectancy less than 12 weeks
  -  major adults protected by French law

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

Clinical trial: Effectiveness of Nursing Case Management for Lung Cancer Patients

Summary: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.

Detailed description: Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.
  Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.
  The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.
  Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.

Eligibility: Inclusion Criteria:
  -  patients with lung cancer
  Exclusion Criteria:
  -  younger than 20 years old

Relevance to patient case: not relevant