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

Clinical trial: Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Summary: Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

Detailed description: All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
  Three study groups are defined using the following inclusion and exclusion criteria:
  -  lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
  -  healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
  -  chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
  For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
  Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
  -  5 BS are presented in 1 experiment:
  -  Test I: lung cancer vs healthy individual
  -  Test II: lung cancer vs chronic obstructive pulmonary disease
  -  Test III: lung cancer vs healthy individuals & bronchitis
  -  for every experiment 1 BS of a lung cancer patient is used
  -  the lung cancer sample is placed randomly in one of the five test tubes
  -  the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  -  neither the dog handler nor the dog know the loading of the test tubes
  -  experiments are repeated 5 to 10 times
  For analysis, the sensitivity and specificity of the dog's reaction is determined.
  The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Eligibility: Inclusion Criteria:
  -  age 18-80
  -  competent
  -  confirmed lung cancer
  Exclusion Criteria:
  -  history of other cancers

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 Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer).

Summary: The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).


Eligibility: Inclusion Criteria:
  1. Signed written informed consent.
  2. Female or male aged 18 years or above.
  3. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
  4. Patients receiving 1st-line treatment for IIIB/IV NSCLC.
  5. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
  6. Tumour not amenable to curative surgery or radiotherapy.
  Exclusion Criteria:
  1. Mixed histology of small cell and non-small cell lung cancer.

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

Clinical trial: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  -  Metastatic disease treated with gefitinib or erlotinib
  -  Presence of at least one measurable lesion according to RECIST criteria
  Exclusion Criteria:
  -  No tumor tissue available
  -  No clinical data available

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 on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma

Summary: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

Detailed description: MSD

Eligibility: Inclusion Criteria:
  -  Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)
  -  Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
  Exclusion Criteria:
  -  Assessment of mutational status of EGFR is not done

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

Clinical trial: Velcade for Proliferative Lupus Nephritis

Summary: The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.

Detailed description: This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.

Eligibility: Inclusion Criteria:
  1. ACR criteria for lupus (minimum 4 out of 11).
  2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
  3. GFR must be greater or equal to 30 cc/min/1.73 m2.
  4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
  5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.
  Exclusion Criteria:
  1. Serum creatinine of more than 3.0 mg/dL on repeated testing.
  2. Greater than 50% fibrosis on renal biopsy.
  3. Platelet count of less than 30× 109/L.
  4. Absolute neutrophil count of less than 1.0 × 109/L.
  5. Greater than or equal to Grade 1 peripheral neuropathy.
  6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
  7. Hypersensitivity to Velcade, boron or mannitol.
  8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
  9. Known history of untreated positive PPD.
  10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.
  11. Diagnosed or treated for another malignancy within 3 years of enrollment.
  12. Greater than 1.5x upper limit of normal total bilirubin.

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 Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

Summary: This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.


Eligibility: Inclusion Criteria:
  -  Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.
  -  For subjects with non-small cell lung cancer only:
  -  Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
  -  A documented mutation in EGFR exons 19 or 21
  -  Subjects must have no further standard of care options or have refused standard therapy
  -  Measurable or evaluable disease
  -  Age ≥ 18 years
  -  ECOG performance < 2
  -  Life expectancy ≥ 3 months
  -  If female, neither pregnant or lactating
  -  If of child bearing potential, must use adequate birth control
  -  Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
  -  Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
  -  Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
  -  Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
  -  Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
  -  Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
  -  Able to render informed consent and to follow protocol requirements.
  Exclusion Criteria:
  -  Anticancer therapy within 4 weeks of study entry.
  -  Use of investigational agent(s) within 30 days of study entry
  -  History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
  -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Subjects with liver cancer and hepatitis may be eligible.

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

Clinical trial: To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.

Detailed description: A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.

Eligibility: Inclusion Criteria:
  -  Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample
  Exclusion Criteria:
  -  Involvement in the planning and/or conduct of the study Previous enrollment in the present 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: Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer

Summary: A large project consisting of:
  a) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.

Detailed description: Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
  This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
  This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.

Eligibility: Inclusion Criteria:
  -  clinical diagnosis of lung cancer
  Exclusion Criteria:
  -  refusal Consent
  -  inability to provide exhaled CO
  -  active psychiatric illness or substance misuse
  -  concurrent malignancies of another type other than non-melanoma skin cancer
  -  unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
  -  WHO performance status 4
  -  Life expectancy less than 6 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: Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

Summary: An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis

Detailed description: Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, and in US, Europe and China it is still under development for APL. Compared to other retinoid drugs available, Tamibarotene has not just a higher activity as a retinoid, but also shows a higher receptor selectivity towards the Retinoic Acid Receptor (RAR) subtypes alfa and beta, but not gamma. All trans retinoic acid (ATRA) and its derivatives are usually pan-agonists to these subtypes, and often are know for the irritation to the skin as one of their major side effects which is due to the RAR gamma subtype. Moreover, unlike ATRA tamibarotene does not cause induction of drug metabolism by CRABP.
  Tamibarotene is known to moderate T1/T2 balance as well as Treg/Th17 balance through binding RAR-alfa receptor, and shows efficacy to various autoimmune and inflammatory animal models.
  In the preliminary clinical research, patients with lupus nephritis for whom prednisolone treatment was not sufficient enough was treated with oral administration of ATRA to show a remarkable decrease in their protein urea (ref. Kinoshita et al, Am.J.Kidney Dis., 2009 Jul 21).
  Based on these results, the investigators plan by this study to evaluate the efficacy of tamibarotene together with the safety to the patients of lupus nephritis.
  Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.

Eligibility: Inclusion Criteria:
  -  Steroid refractory lupus nephritis
  -  more than 10mg of steroid failed to control disease activity
  -  patients who failed to reduce the amount of steroid
  -  patients who couldn't increase the amount of steroid due to side effects
  -  Urine Protein creatinine raio > 0.5 or RBC in urine >= 6 /HPF
  -  Anti dsDNA antibody > 10 IU/ml or complement C3 < 84 mg/dl
  -  Patients willing to take contraceptive measures throughout the study and for female patients two years after the study and for men six months after the study.
  Exclusion Criteria:
  -  Pregnant or breastfeeding female patients
  -  Hepatic failure patients
  -  Triglyceride > 500 mg/dl
  -  Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 8 weeks prior to test drug administration
  -  Patients who received cyclophosphamide puls within 6 months prior to test drug administration
  -  Patients with diabetics (HbA1c > 8.0%)
  -  Serum creatinine ≧1.5mg/dL
  -  CNS( Central Nerve System) Lupus patients

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 Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Summary: This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic NSCLC with EGFR mutations
  -  Measurable disease according to RECIST criteria
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Previous chemotherapy or therapy against EGFR for metastatic disease
  -  Symptomatic cerebral metastases
  -  Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
  -  History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  -  Concomitant use of coumarins

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 Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Summary: This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
  -  Measurable disease according to RECIST criteria
  -  ECOG performance status 0-2
  -  Adequate haematological, renal and liver function
  Exclusion Criteria:
  -  Previous chemotherapy or therapy against EGFR for metastatic disease
  -  History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  -  Symptomatic cerebral metastases
  -  Pre-existing parenchymal lung disease such as pulmonary fibrosis
  -  Concomitant use of coumarins

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 Study of Tarceva (Erlotinib) as First Line Therapy in Patients With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Summary: This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in patients with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All patients will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, patients may receive Tarceva beyond disease progression.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Stage IV or recurrent non-small cell lung cancer (NSCLC)
  -  Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
  -  Measurable disease (at least one lesion >= 10 mm in longest diameter)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Patients with T790M single mutation only
  -  Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
  -  Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
  -  Symptomatic or uncontrolled central nervous system (CNS) metastases
  -  Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
  -  Any significant ophthalmologic abnormality
  -  Pre-existing parenchymal lung disease such as pulmonary fibrosis
  -  Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

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

Clinical trial: Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)

Summary: The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.


Eligibility: Inclusion Criteria:
  -  Pathologically proven NSCLC
  -  Ineligibile for curative treatment (namely, stage IIIb or IV)
  -  History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
  -  At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
  -  18 years old or older
  -  Performance status ECOG 0-2
  -  Adequate organ function as evidenced by the following:
  -  Absolute neutrophil count > 1.0 x 109/L
  -  Platelets > 75 x 109/L
  -  Total bilirubin ≤ 1.5 UNL
  -  AST and/or ALT < 5 UNL
  -  Creatinine clearance ≥ 45mL/min
  Exclusion Criteria:
  -  Previous EGFR TKI therapy history
  -  Systemic anticancer therapy within the previous 3 weeks
  -  Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
  -  Other concurrent illness that would preclude study participation (severe heart disease)
  -  Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
  -  Pregnant or nursing

Relevance to patient case: possibly relevant