araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

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
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer

Summary: A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed lung cancer, excluding small cell carcinoma
  -  Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998
  -  The primary tumor must be radiographically measurable.
  -  Age > 18.
  -  Karnofsky performance status > 70.
  -  FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually > 800 ml
  -  Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min.
  -  Laboratory values must be obtained < 3 weeks prior to registration.
  -  A signed informed consent.
  -  Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.
  Exclusion Criteria:
  -  Patients with medical contraindication to chemotherapy or radiotherapy.
  -  Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.
  -  Women who are pregnant.
  -  Patients with small cell carcinoma or mesothelioma

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Radiofrequency Ablation of Lung Tumors

Summary: Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).

Detailed description: Radiofrequency (RF) ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that RF can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms with a minimal follow-up of one year. The primary endpoint was to determine the rate of incomplete local treatment at 1 year. The secondary endpoints were to evaluate tolerance, survival, disease-free survival and lung tumor-free survival. Patients are followed-up by CT scan examination at day 1 or 2 before discharge from the hospital, then at 2, 4, 6, 9 and 12 months and then at 2 years

Eligibility: Inclusion Criteria:
  -  Unilateral or bilateral unresectable primary or metastatic lung tumors <= 40 mm and a number of tumor <=5
  -  Tumors located more than 1 cm from the hilum, and not involving soft tissues or mediastinum.
  -  Malignancy histologically proven for pulmonary nodules in patients with no history of cancer outside the lung.
  -  Lung tumors in patients with a known distant cancer history, has to be either histologically proven or a demonstrated change in size of at least 25% in their largest diameter is required on CT during the previous year
  -  Pretreatment imaging work-up within 4 weeks of scheduled RF ablation (at least a chest CT and an abdomino-pelvic CT)
  -  If a tumor is found outside the lung, it has to be amenable to complete eradication with RF or RF plus surgery
  -  Lung spirometry within 4 weeks of treatment with a FEV1 >= 1 liter
  -  Written informed consent.
  Exclusion Criteria:
  -  Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Minimum Dose CT Post Lung Biopsy

Summary: The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy

Detailed description: Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax

Eligibility: Inclusion Criteria:
  -  All Patients having a lung biopsy
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Summary: Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status

Detailed description: Upon determination of eligibility, patients will be receive:
  -  ZD1839

Eligibility: Inclusion Criteria:
  To be included in this study, you must meet the following criteria:
  -  Biopsy proven non-small cell lung cancer
  -  Recurrent non-small cell lung cancer after previous surgery or radiation
  -  Advanced disease (stage IIIb or IV)
  -  No previous chemotherapy or biological therapy
  -  Require significant assistance with activities of daily living
  -  Measurable disease
  -  Adequate bone marrow, liver and kidney function
  -  Give written informed consent
  Exclusion Criteria:
  You cannot participate in this study if any of the following apply to you:
  -  Brain metastasis
  -  Meningeal metastasis
  -  Other uncontrolled malignancies
  -  Women pregnant or lactating
  -  No measurable disease outside previous radiation therapy field
  Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Summary: This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Detailed description: Upon determination of eligibility all patients will receive:
  -  Docetaxel + Gemcitabine + Cetuximab

Eligibility: Inclusion Criteria:
  To be included in the study, you must meet the following criteria:
  -  18 years of age or older
  -  Non-small cell lung cancer confirmed by biopsy
  -  Unresectable stage III or IV disease
  -  Measurable disease
  -  Must not have received any prior chemotherapy for lung cancer
  -  Able to perform activities of daily living without considerable assistance
  -  Adequate bone marrow, kidney, and liver function
  -  Signed informed consent
  Exclusion Criteria:
  You cannot participate in the study if any of the following apply to you:
  -  History of serious heart disease within six months prior to study entry
  -  Prior treatment with agents that target the EGFR pathway
  -  History of any other uncontrolled or significant disease
  Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1

Summary: Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

Detailed description: Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.
  Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
  This observational case-control study will involve a random selection from a group of smokers who are participating in the Prostrate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial. The chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). Demographic and baseline data from the PLCO database will be obtained. Prior baseline blood samples from the PLCO trial will be obtained as well. Based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. These samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. This study will not involve recruitment of any participants, as data and samples from the PLCO trial will be used and no new blood samples will be obtained.

Eligibility: Inclusion Criteria:
  -  Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
  -  Reported smoking on baseline questionnaire of PLCO
  -  Contributed biorepository samples
  Exclusion Criteria:
  -  Unstable physical or mental health

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lung Cancer Case Registry and Tissue Resource

Summary: Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the Cancer Research and Treatment Center (CRTC) and New Mexico Veterans Health Care System (NMVHCS).

Detailed description: Lung cancer is the most common cause of cancer death in the US in both men and women. This research study will enroll lung cancer patients into a registry to study changes in DNA (or genetic material) that may be associated with development of lung cancer or other lung diseases such as chronic obstructive pulmonary disease (COPD). We will also study the role of eating habits on lung cancer diagnosis and treatment, as well as the effects of the disease and treatment on quality of patient's lives.

Eligibility: Inclusion Criteria:
  -  Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the CRTC and NMVHCS. Recruiting will primarily be performed through the Multidisciplinary Chest Clinics held weekly at each hospital. These clinics are staffed by the Principal Investigator (PI) and Reza Mehran, MD, a thoracic surgeon at both hospitals and a co-investigator on this submission. Approximately 90% of all lung cancer cases diagnosed at the NMVHCS, and a somewhat smaller proportion of cases treated in the Cancer Center, are seen in these clinics. Additional cases will be identified through review of new patient visits to each hospital with a diagnosis of lung cancer; Drs. Crowell and Mehran also maintain weekly contact with pathology and oncology services at both facilities, which will facilitate case identification at NMVHCS and University Hospital. Finally, patient contact records will be correlated with tumor registry records at both hospitals, which will identify any cases not captured through the above mechanisms. Although these cases may be identified several weeks after initial diagnosis, all attempts will still be made to contact the patient and family for enrollment into the registry. Most Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual, and a language barrier has not been a problem in other similar studies conducted by the PI. However, Spanish-speaking personnel are available to obtain consent and answer any questions if necessary.
  Exclusion Criteria:
  -  Patients will be excluded if they cannot provide written informed consent.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

Summary: To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

Detailed description: 1. To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
  2. To enhance the proportion of complete remission
  3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity

Eligibility: Inclusion Criteria:
  -  HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
  -  Female < 70yrs
  -  Histologically or cytologically proven breast cancer.
  -  Metastatic or locally advanced breast cancer (clinical stage: III-IV)
  -  Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
  -  Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
  Exclusion Criteria:
  -  History of cardiopathy
  -  Severe hepatic and renal diseases
  -  Brain metastases as the only parameter of disease
  -  Contraindication to the use of corticosteroids as premedication
  -  Acute infectious diseases
  -  Insulin-dependent diabetes
  -  History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
  -  Concurrent treatment with any other cancer therapy

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Fitness and Exercise for People With Arthritis

Summary: The purpose of this study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.

Detailed description: There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:
  1. To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.
  2. Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.
  3. Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.
  4. Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.

Eligibility: Inclusion Criteria:
  -  Self-reported doctor-diagnosed arthritis
  -  No physical limitations precluding exercise participation
  -  Negative screen for CVD (PAR-Q)
  -  Age 20+
  -  English or Spanish speaking
  Exclusion Criteria:
  -  Presence of any condition for which exercise is contraindicated
  -  Physical inability to complete exercise program

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: The Serum Tissue Factor Level in Lung Cancer Patients as a Prognostic Factor

Summary: This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status with clinical staging and prognosis.

Detailed description: The staging of lung cancer was according to tumor size, involvement of lymph node and metastatic status. But there is a different prognosis in cancer patients of the same stage. The coagulation status of cancer patients was considered as an important possible prognostic factor. So in this study, we want to evaluate patients' coagulation status and find the relation of coagulation status and cancer status.
  We thus propose a prospective study using coagulation factors in order to search for the relationship between cancer stage and pre-coagulation status in Taiwanese lung cancer patients. We will also evaluate the potential use of tissue factor as a prognosis predictor in lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Patients with newly-diagnosed lung cancer
  -  Serum from cancer-free healthy volunteers
  Exclusion Criteria:
  -  Chronic renal failure or end-stage renal disease [ESRD] (creatinine [Cr] > 2 )
  -  Hyperlipidemia on statin therapy
  -  Acute myocardial infarction
  -  Tapal or Plavix use
  -  Active thromboembolic event
  -  Severe liver disease (> child B)

Relevance to patient case: not relevant