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 Effect of Calcitriol on Progress and Activity of Lupus Nephritis

Summary: The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Detailed description: Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.

Eligibility: Inclusion Criteria:
  -  Aged 18-65 years
  -  Baseline Systemic Lupus Erythematosus Disease Activity Index score <= 4
  -  Estimated glomerular filtration rate more than 15 ml/min/1.73m2
  -  Proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
  -  On maintenance dose of prednisolone < 15 mg/day with or without other immunosuppressive medications
  -  Serum calcium level in normal range( 8.5-10.5 mg/dl)
  -  History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
  -  Willingness to give written consent and comply with the study protocol
  Exclusion Criteria:
  -  Pregnancy, lactating or childbearing potential without effective method of birth control
  -  Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
  -  History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry
  -  Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
  -  History of drug or alcohol abuse within past 2 years
  -  Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
  -  Participation in any previous trial on vitamin D analogue
  -  Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks
  -  Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D
  -  On other investigational drugs within last 30 days
  -  History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
  -  History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs

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

Clinical trial: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer

Summary: Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
  Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
  Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
  During the evaluation the following tests will be done:
  -  Anthropometric measures
  -  Level of daily physical activity
  -  Pulmonary function test
  -  Maximal incremental cardiopulmonary exercise test on ergocycle
  -  Endurance test on ergocycle
  -  Muscle function tests
  -  Magnetic stimulation
  -  Quadriceps biopsy


Eligibility: Inclusion Criteria:
  -  Men and women with a primary lung cancer diagnosis
  Exclusion Criteria:
  -  Already have undertaken surgery, chemotherapy or radiotherapy treatment
  -  Having an other cancer in the last five years
  -  Taking anticoagulation 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: Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC

Summary: New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult.
  Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.
  The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.


Eligibility: Inclusion Criteria:
  -  Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment
  Exclusion Criteria:
  -  pregnancy
  -  severe dyspnoea

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 LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Summary: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
  -  Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
  -  Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  -  Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
  -  Availability of adequate tumor material (block or slides)
  Exclusion Criteria:
  -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
  -  Have previously completed or withdrawn from this study or any other study investigating LY2875358
  -  Have a serious concomitant systemic disorder or significant cardiac disease
  -  Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
  -  Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
  -  Have major surgery less than 2 weeks prior to the initiation of study treatment therapy
  -  Pregnant or lactating women

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

Clinical trial: the Quality of Life Assessment of Lung Cancer Patients in China

Summary: The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

Detailed description: 1. Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable.
  2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Eligibility: Inclusion Criteria:
  -  age: >18 and <75 years old
  -  pathological or cytological diagnosis confirmed advanced non-small cell lung cancer
  -  Eastern Cooperative Oncology Group Performance Status: 0-2
  -  have never receive any kind of anti-cancer chemotherapy
  -  agree to regularly assessment of quality of life
  -  sign the informed consent form
  Exclusion Criteria:
  -  Currently attending any antitumor drug clinical trials
  -  Pregnancy or breast-feeding women
  -  Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.
  -  not suitable to participate in this test

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-drug Study Profiling Cutaneous Lupus

Summary: The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.

Detailed description: This is a Phase 0, multiple-center observational study of biomarkers and clinical parameters in patients with lupus, including discoid lupus erythematosus (DLE), subacute cutaneous LE (SCLE) and active systemic lupus erythematosus (SLE). There is no study-related therapeutic intervention and this protocol will not restrict or introduce any medical interventions including medications. Study participants will undergo procedures that include collection of urine, blood samples, and skin biopsy. At least 30 participants (≥10 DLE, ≥10 SCLE, and ≥10 SLE) will be enrolled in this study. All participants will continue to be managed by their personal physicians per their standard of care. The data obtained in this study will help in the evaluation of new therapeutics for lupus and may facilitate lupus drug discovery. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. There will be a single sample collection time point for each patient. The safety assessments will include laboratory measurements (serum chemistry and hematology), monitoring of adverse events (AEs) related to study procedures, and physical examination.

Eligibility: Inclusion Criteria:
  -  have active DLE or active SCLE confirmed by histological analysis
  -  have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA
  -  have an active skin lesion that can be biopsied
  -  if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.
  Exclusion Criteria:
  -  have an active skin disease other than CLE
  -  have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)
  -  have used a topical corticosteroid on active lesion
  -  have donated blood (volume >=500 mL) within 56 days prior to screening
  -  has been treated with drugs that are associated with CLE induction within 2 months prior to the screening
  -  have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.

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

Clinical trial: Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

Summary: The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

Detailed description: The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

Eligibility: Inclusion Criteria:
  -  Non-suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung nodule lesion in the chest (based on local CT result);
  4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  -  Suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung cancer lesion in the chest (based on local CT result);
  4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  Exclusion Criteria:
  -  Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
  -  Already treated by chemotherapy or surgery

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 Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Summary: This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Detailed description: Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  The patients signed the written informed consent
  -  The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
  -  The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
  -  The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
  Exclusion Criteria:
  -  Patients with unresected tumor
  -  Wild EGFR type
  -  Allergic to the study drug
  -  Patients have severe non-cancerous diseases
  -  Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

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

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

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

Clinical trial: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  EGFR mutation or six months or longer benefit from EGFR TKIs
  -  Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  -  Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
  Exclusion Criteria:
  -  Inability to take oral drugs

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

Clinical trial: Rapid Learning for Lung Cancer

Summary: A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Detailed description: By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility: Inclusion Criteria:
  - Patients notes as suffering from lung cancer in at least one clinical data source.

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

Clinical trial: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Clinical trial: Immune Response in Lung Cancer

Summary: This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-1
  -  Patients with histologically documented non-small cell lung cancer
  -  Control group - patients without non-small cell lung cancer
  -  Written (signed) Informed Consent to participate in the study
  Exclusion Criteria:
  -  Any other malignancies within 5 years
  -  Any unstable systemic disease (including active infections, significant cardiovascular disease)
  -  Prior chemotherapy or radiotherapy
  -  Autoimmune disease
  -  Nursing or pregnant women

Relevance to patient case: not relevant