araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Summary: Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
  Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
  Secondary Objectives:
  -  To estimate overall survival (OS) which will serve as the primary efficacy signal.
  -  To explore an association of T cell responses and immunological responses with OS in patients receiving treatment.
  -  To estimate overall response rate (ORR), immune related best overall response rate (irBOR), progression free survival (PFS), and duration of response in patients receiving treatment.
  -  To explore an association between immune-related adverse events (IRAEs) and ORR.
  -  To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.


Eligibility: Inclusion Criteria:
  1. Documented cancer of the pancreas who have failed (or are not candidates for) standard therapy
  2. ECOG Performance Status of 0 to 1
  3. Adequate organ function as defined by study-specified laboratory tests
  4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  5. Signed informed consent form
  6. Willing and able to comply with study procedures
  Exclusion Criteria:
  1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
  2. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  3. Systemically active steroids
  4. Another investigational product within 28 days prior to receiving study drug
  5. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
  6. Infection with HIV, hepatitis B or C at screening
  7. Pregnant or lactating
  8. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: A Study for Patients With Pancreatic Cancer

Summary: The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618 when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate whether LY2603618 when administered 24 hours after gemcitabine therapy is an effective treatment for patients with pancreatic cancer.

Detailed description: Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts. Each patient will be assigned to a single cohort with no intrapatient dose escalation. Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9, and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients total to determine the maximum tolerated dose to be carried into the phase 2 portion of the study.

Eligibility: Inclusion Criteria:
  -  Diagnosed with cancer that is metastatic and/or advanced during Phase 1
  -  Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
  -  Must be 18 years of age
  -  Adequate hematological, liver, and renal functions
  -  ECOG status 0-2
  Exclusion Criteria:
  -  Known hypersensitivity to gemcitabine
  -  Pregnant or lactating females or refusal to use medically approved contraceptive precautions
  -  Had prior treatment with radiotherapy involving more than 25% of marrow producing area
  -  Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Integrated Positron Emission Tomography - Computed Tomography (PET-CT) in Patients With Pancreatic Cancer

Summary: In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.
  After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.
  In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.

Detailed description: Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.

Eligibility: Inclusion Criteria:
  -  Pancreatic mass suspicious of pancreatic cancer
  -  No comorbidity, expected life expectancy less than 6 months
  -  Consent this study in letter
  Exclusion Criteria:
  -  Refuse diagnostic and staging work-up

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of Proteins in Head and Neck Cancer Cells

Summary: RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.

Detailed description: OBJECTIVES:
  -  Define the function and mechanism of LZAP in regulating ARF.
  -  Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
  -  Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.
  OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.

Eligibility: DISEASE CHARACTERISTICS:
  -  Head and neck cancer tumor cell line
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed description: OBJECTIVES:
  -  Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
  -  Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
  -  Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
  OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
  Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
  Patient data related to relapse and recurrence is collected, if available.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed diagnosis of cutaneous melanoma
  -  Breslow thickness > 0.75 mm
  -  Has undergone sentinel lymph node biopsy
  -  No primary melanoma that has not originated in the skin
  -  No multiple primary melanomas
  -  Currently under clinical followup OR discharged from follow up within the past 3 months
  PATIENT CHARACTERISTICS:
  -  No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Identification of Biomarkers for Early Detection of Pancreatic Cancer

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer.
  -  Analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis.
  OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) and/or electrospray mass spectrometry (ESI/MS).
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of pancreatic cancer
  -  Newly diagnosed disease
  -  Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer.
  -  Characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients.
  OUTLINE: Fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of pancreatic adenocarcinoma of exocrine origin
  -  Metastatic disease
  -  Fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy for pancreatic cancer

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
  -  To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.
  OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).
  Patients are followed for recurrence, relapse, and death from disease.

Eligibility: Inclusion criteria
  -  Diagnosis of pancreatic cancer
  -  Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis
  Exclusion criteria
  -  None known

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of Tumor Samples From Patients With Ewing Sarcoma

Summary: This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples collected from AEWS0031 and patients registered on AEWS08B1 Sampling Method: Non-Probability Sample
  PRIMARY OBJECTIVES:
  I. Determine if mutation of p53, and/or deletion of the p16 locus, have prognostic value in patients with Ewing sarcoma.
  SECONDARY OBJECTIVES:
  I. Estimate the incidence of p53 mutation in Ewing sarcoma samples collected from COG studies.
  II. Estimate the incidence of p16 deletions in Ewing sarcoma samples collected from COG studies.
  III. Prepare and archive amplified genomic DNA from Ewing sarcoma samples collected from COG studies for future biologic analysis.
  OUTLINE: This is a multicenter study.
  Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Ewing sarcoma
  -  Banked specimens from patients enrolled on AEWS0031

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.
  PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.

Detailed description: OBJECTIVES:
  -  Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
  -  Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
  -  Test new hypotheses as they emerge.
  OUTLINE: This is a prospective study.
  Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.
  PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Histologically confirmed pancreatic malignant neoplasm
  -  Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
  -  Healthy, at-risk participant meeting the following criteria:
  -  Smoker, diabetic, and/or has a family history of pancreatic cancer
  -  Healthy participant (no history of cancer)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

Summary: RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.
  PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
  -  To assess the variability in number of CTCs between patients with the same tumor type.
  -  To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.
  OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

Eligibility: DISEASE CHARACTERISTICS:
  -  Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No history of any prior cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior therapy for metastatic disease

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To identify TAB3 transcript/protein as a molecular marker of cancer, specifically testicular, skin, small intestine, and pancreatic cancer.
  -  To characterize TAB3 and its signaling networks that are involved in tumorigenesis.
  OUTLINE: Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

Eligibility: DISEASE CHARACTERISTICS:
  -  Paraffin tissue blocks from surgical pathology cancer cases, specifically testicular, skin, small intestine, and pancreatic cancer, available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Studying Biomarkers in Patients With Pancreatic Cancer

Summary: RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To determine whether the cellular localization of BRCA1 can predict how patients with pancreatic cancer will respond to cytotoxic agents (e.g., fluorouracil or gemcitabine hydrochloride) or radiotherapy.
  -  To identify pre-treatment markers that can be used to correlate with clinical outcomes of survival and recurrence.
  -  To determine if a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue can now be applied to the pancreatic cancer population.
  OUTLINE: Tissue samples from biopsies performed during pancreatectomy are collected from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core for laboratory biomarker studies. Proteins secreted by cancer cells and/or cancer-associated cells are studied by extracting and identifying secreted cytokines and growth factors from biopsy tissue. The integrity of the DNA repair pathway in pancreatic cancer is analyzed by Rad51 and phosphorylated DNA-PK foci formation. Markers are correlated with clinical outcome.
  Patients are followed for recurrence, relapse, and death from disease.

Eligibility: Inclusion criteria
  -  Any subject with excess tissue collected at time of routine surgery for pancreatic cancer is eligible.
  -  All subjects participating in this protocol will be followed for recurrence, relapse and death from disease

Relevance to patient case: not relevant