araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer

Summary: The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.


Eligibility: Inclusion Criteria
  Patients will be eligible for the study if they:
  -  Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
  -  Have an ECOG performance status of Zero or One
  -  Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer
  -  (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment
  -  (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain.
  -  Have signed an informed consent form
  Exclusion Criteria
  Patients will not be eligible for this study if they:
  -  Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
  -  Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
  -  Are taking or have taken part in any investigational study within 30 days of start of study
  -  Have received an indium agent within 30 days of start of study
  -  Are not able to remain immobile during scanning time
  -  Have taken drugs that may damage the kidneys within 2 weeks of start of study
  -  Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal
  -  Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration
  -  Have undergone a PET scan within 7 days prior to study drug administration
  -  Have any active or previously treated second malignancy except carcinoma in situ of the uterine cervix or non-melanoma skin cancer

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description: This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility: Patients must have:
  -  Pathologic (histologic or cytologic) confirmation of NSCLC
  -  Stage IIIB with malignant pleural effusion or Stage IV disease
  -  At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
  -  ECOG performance status 0 or 1
  -  Adequate organ system function
  -  Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
  Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
  Patients must not have had:
  -  Brain metastasis
  -  Prior chemotherapy for NSCLC
  -  Prior platinum-based chemotherapy for any indication

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description: This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility: Patients must have:
  -  Pathologic (histologic or cytologic) confirmation of NSCLC
  -  Stage IIIB with malignant pleural effusion or Stage IV disease
  -  At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
  -  ECOG performance status 0 or 1
  -  Adequate organ system function
  -  Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
  Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
  Patients must not have had:
  -  Brain metastasis
  -  Prior chemotherapy for NSCLC
  -  Prior platinum-based chemotherapy for any indication

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

Summary: This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens.
  The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include:
  -  To further evaluate the safety of EKB-569
  -  To explore additional clinical activity parameters
  -  To explore subject survival
  -  To evaluate the pharmacokinetics of EKB-569
  -  To assess subject reported outcomes
  EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility: Inclusion Criteria:
  -  Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
  -  Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas)
  -  Prior radiotherapy to >25% of bone marrow
  -  Prior epidermal growth factor receptor-targeting therapy

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Histologically confirmed non-small cell lung cancer (NSCLC)
  -  Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
  -  Measurable disease by RECIST
  -  ECOG status of 0-1
  -  Adequate liver and renal function
  -  Adequate bone marrow reserves
  Exclusion Criteria:
  -  Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
  -  Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
  -  History of bone marrow transplantation or stem cell support
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Summary: The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
  A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
  Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years old
  -  ECOG score of 0, 1, or 2
  -  Histologically confirmed diagnosis of non-small cell lung cancer
  Exclusion Criteria:
  Laboratory values demonstrating inadequate function of the following:
  -  Bone marrow
  -  Kidneys
  -  Liver
  and
  -  Peripheral neuropathy Grade 2 or higher
  -  Greater than 2 prior chemotherapy regimens

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Celecoxib Treatment for Lung Cancer

Summary: This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy
  Exclusion Criteria:
  Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)

Summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.


Eligibility: Inclusion Criteria:
  -  Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
  -  Immunohistochemical evidence of EGFR expression on tumor tissue
  -  Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area
  Exclusion Criteria:
  -  Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
  -  Previous chemotherapy for NSCLC
  -  Documented or symptomatic brain metastasis
  -  Superior vena cava syndrome contra-indicating hydration
  -  Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: SERPIN D1 and Its Role in Lung Cancer Invasion and Metastasis

Summary: To evaluate the correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Detailed description: Lung cancer is the leading cause of cancer death in Taiwan and world wild. Although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. In many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. Only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. The remaining almost died of metastatic disease. Detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. Molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. By using tools in SAGE Genie of Cancer Genome Anatomy Project (CGAP), we identified a secreted protein, SERPIN D1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. In an established panel of human lung adenocarcinoma cell lines with different invasive activities (CL1–0 cells and its sublines CL1–1, and CL1–5, in ascending order of activity), we detected that the expression of SERPIN D1 was higher in CL1-5 than in CL1-0 and CL1-1. According to our preliminary results, we hypothesize that SERPIN D1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. For this study, we are going to evaluate the potential correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Eligibility: Inclusion Criteria:
  -  non-small cell lung cancer patient, pathological proved
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Molecular Mechanism of Trophinin in Cancer Invasion and Metastasis

Summary: Our study established a model combine the in silico biology and empirical methods to identify clinically useful biomarker from information of microarray gene expression profiles in public domain. Through this method, we found trophinin as a novel prognostic marker for early stage lung cancer, which provide insight towards the process of cancer metastasis and the potential target for treatment.

Detailed description: This study was to combine the in silico biology and empirical methods to identify clinically useful biomarker of lung cancer from microarray gene expression profiles in public database.
  Using the expression profile of a known metastasis suppressor, CRMP-1, as a template to search for and compare transcriptome expressions in publicly accessible microarray datasets, trophinin (TRO) was identified as the best correlated gene. The expression pattern of trophinin in a lung cancer cell lines of invasion model was investigated using quantitative RT-PCR. The role of trophinin in cancer metastasis was investigated by measuring the change of invasion activity in trophinin gene-transfected cell lines. The relationship of trophinin and the clinicopathological characteristics of lung cancer were further examined by immunohistochemical staining.

Eligibility: Inclusion Criteria:
  -  patients who underwent surgery for non-small-cell lung cancer at the National Taiwan University Hospital from 1991 to 2000 with available stored tissue blocks were included as potential subjects in this study.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC)

Summary: The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, based on resources and outcomes from patients who met the inclusion criteria for this naturalistic study comparing to existing first line platinum-based regimen chemotherapy.

Detailed description: Patients with late-stage NSCLC are often symptomatic, with specific pulmonary problems (eg, cough, breathlessness, hemoptysis) and general symptoms (eg. fatigue, weight loss) that can cause extreme distress to the patient. Therefore, improvements in disease-related symptoms and quality of life (QoL) are the key desired outcomes of medical management.7 Effective, palliative, low-toxicity with reasonable treatment cost for patients with advanced NSCLC are needed. Recently, more and more countries consider evidence of economic value along with clinical efficacy.
  The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC. 8,9 Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. 10-12 EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE).13 Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed stage IIIB/IV NSCLC No immediate need for palliative radiotherapy and No prior chemotherapy ; age > 20 Y/O; ECOG PS: 0 - 2; ANC >2000 ; PLT >100k ; Hb > 10; total bilirubin < 2.0 mg/dL; serum creatinine < 2 mg/dl; SGPT and SGOT < 2.5 ×ULN, alkaline phosphatase < 5 ×ULN ; life expectancy >6mos
  Exclusion Criteria:
  -  If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy;
  -  2nd malignancies;
  -  Unable to swallow tablets;
  -  Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements;
  -  Pregnant or lactating patients;
  -  Participation in other clinical trials within 30 days of study entry;
  -  Major systemic disease which in the investigator's opinion might confound the clinical trial.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Methylation Status of CD44 Promoter Region in Primary Lung Cancer

Summary: This project is to study the methylation status of the transcriptional regulatory region of CD44 gene in surgically resected NSCLC specimens and normal lung tissue, correlate the methylation status of promoter region with the expression of CD44 gene, and analyze if methylation is associated with survival.

Detailed description: CD44 is a cell surface receptor for the extracellular matrix hyaluronan. It mediates adhesion of cells to the extracellular matrix. Its ability to organize extracellular matrix into a medium is also used by cancer cells in their becoming metastatic. Invasive tumor cells are frequently observed to bind hyaluronate.
  CD44 gene is made up of 20 exons, at least 10 of which are variably expressed due to alternative splicing of the mRNA. The standard form, CD44s, has a coding sequence of exons 1-5 and 16-20. Variant isoforms (CD44v), all larger, arise from alternative splicing of combinations of exons 6-15 (v1-10). A variant isoform CD44 can induce metastasis of a rat pancreatic carcinoma. Studies in human tumors, however, have produced variable results. Some breast cancers demonstrate positive correlation between CD44v expression and tumor progression, while others lack any correlation. Some colorectal tumors even show an inverse correlation. CD44 has also been demonstrated to be a metastasis suppressor gene for prostate cancer. Thus, CD44 may be a marker for metastasis for some tumors, but not for others, and it may actually be a metastasis suppressor gene for yet another groups of tumors.
  For primary lung cancer, the correlation between CD44 expression and tumor metastasis has not been established. The metastasis-prone small cell lung cancer rarely showed any immunohistochemical staining for CD44s or CD44v. For non-small cell lung cancer (NSCLC), some studies showed positive correlation between immunohistochemical CD44v expression and tumor progression, while others showed no correlation. Our own study using RT-PCR, sequencing and immunohistochemical staining showed that in pulmonary adenocarcinoma, CD44v6 expression is down-regulated as the disease progressed. Based on our finding, and the observation that CD44s and CD44v expression are low in metastasis-prone small cell lung cancer, we assue that CD44 is a metastasis suppressor gene which is inactivated in lung cancers. Because in prostate cancer DNA hypermethylation has been shown to be related to the down-regulation of CD44 gene, we plan to study the methylation status of the transcriptional regulatory region of CD44 gene in primary lung cancer. We’ll study CD44 expression by immunohistochemistry, the methylation status of CD44 regulatory region by sequencing of the bisulfite-modified genomic DNA, and correlate these two findings with each other, and with histologic type, tumor staging and survival.

Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer
  Exclusion Criteria:

Relevance to patient case: not relevant