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

Clinical trial: Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

Summary: The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.


Eligibility: Inclusion Criteria:
  -  locally advanced pancreatic cancer
  -  performance status 0-2
  -  normal blood count and chemistry
  -  no previous chemotherapy or radiotherapy
  Exclusion Criteria:
  -  serious concurrent systemic 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: Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)

Summary: The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.

Detailed description: Efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing. Some patients are at increased risk of pancreatic cancer or may have pre-malignant pancreatic lesions which predispose them to later pancreatic cancer development. In these individuals, chemopreventative measures may block future development of pancreatic cancer. Human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests that cyclooxygenase-2 (COX-2) may be a successful target for chemoprevention. COX-2 is overexpressed in human pancreatic cancers. Elevated COX-2 expression correlates with progression of premalignant precursors of pancreatic cancer in development models of hamster pancreatic cancer. Human tissue studies confirm increases in COX-2 expression with progression of premalignant precursors called intraductal papillary mucinous neoplasms (IPMNs) and pancreatic intraepithelial neoplasms (PanINs). Moreover, COX-2 inhibitors appear to have chemopreventative efficacy in the PC-1 homograft model of hamster pancreatic cancer. Demographic studies have suggested COX-2 inhibitors may confer protection from pancreatic cancer. We propose to conduct a pilot/phase II trial to determine the chemopreventative effects of the COX-2 inhibitor celecoxib in patients with premalignant pancreatic lesions.
  Patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to surgery (if patient decides to have surgery for his/her condition). If subject is not a surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of IPMN
  -  ECOG Performance status of 0, 1, or 2
  -  Adequate liver function, bilirubin < 1.5 times ULN, ALT or AST < 2.5 times ULN
  -  Adequate renal function: creatinine < 1.8
  -  Must be at least 18
  Exclusion Criteria:
  -  Use of COX-2 selective inhibitors within the last month
  -  More than occasional use of NSAIDS in last month (occasional use defined as up to twice weekly dosing)
  -  CA19-9 levels 1.5 times the ULN
  -  Active pancreatitis
  -  Taking sulphonylureas, fluconazole or lithium concomitantly

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

Clinical trial: Cancer Detection in Pancreatic Cysts

Summary: The purpose of this study is to assist with early and accurate diagnosis of cancer in pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine needle aspiration

Detailed description: The study of pancreatic diseases is hindered by the organ's deep seated location and especially lack of symptoms during the early stages of disease development and progression e.g. pancreatic cancer. This is particularly true of pancreatic cysts, the variety and the malignant potential of which encompass a broad spectrum. The radiological features distinguishing a benign from a pre-malignant to a frankly malignant cyst in the pancreas are frequently underwhelming and have lead to the clinical practice of sampling all but the most obvious. The yield of the aspirate in turn is frequently not of a quality upon which a clinical decision can be based.
  Most would agree that the best approach for management of pancreatic cystic neoplasm lies in early diagnosis, ideally at a precancerous stage. The effectiveness and applicability of this study is the based on the ability of the cyst DNA analysis to stratify the patients at risk of developing pancreatic cancer based on the extent of accumulated mutational damage.

Eligibility: Inclusion Criteria:
  -  Previously scheduled for Endoscopic ULtrasound for evaluation of pancreatic cyst
  Exclusion Criteria:
  -  Any condition that would preclude safe performance of EUS/FNA

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

Clinical trial: Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

Summary: The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

Detailed description: The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

Eligibility: Inclusion Criteria:- Pancreatic tumors not to exceed 7.5 cm.
  -  Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
  -  Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
  -  Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
  -  Eastern Clinical Oncology Group performance status 0, 1 or 2.
  Exclusion Criteria:Chemotherapy within 1 month of registration.

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

Clinical trial: Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Summary: To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Detailed description: To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  pathologically confirmed adenocarcinoma of the pancreas
  -  resectable disease
  -  tumor </= 6cm diameter
  -  ECOG performance 0-1
  -  Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili</=2mg; liver enzymes <2.5ULN; crt </=1.5;
  -  Normal CXR
  -  Negative pregnancy test
  Exclusion Criteria:
  -  metastatic disease or peritoneal seeding based on cross-sectional imaging
  -  previous irradiation to the planned field
  -  prior chemotherapy or immunotherapy
  -  active infection
  -  active PUD

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

Clinical trial: Lifestyle Intervention in Obese Arab Women

Summary: The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women

Detailed description: 200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.

Eligibility: Inclusion Criteria:
  -  Obesity (BMI: 30-40 kg/squared meter)
  -  Female Gender
  -  Being 35-54 years old
  Exclusion Criteria:
  -  Diabetic
  A contraindication for physical activity

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

Clinical trial: Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

Summary: To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study


Eligibility: Inclusion Criteria:
  -  Subjects with unresectable locally advanced or metastatic pancreatic cancer
  -  KPS > 70%
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  received previous chemotherapy for the current indication
  -  received previous radiotherapy for the current indication
  -  Currently receiving chemotherapy

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

Clinical trial: Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Summary: The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Metastatic or unresectable pancreatic cancer
  -  No prior chemotherapy except radiation-sensitizing doses of 5-FU
  -  No radiotherapy less than 4 weeks prior to the start of the study
  Exclusion Criteria:
  -  Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
  -  Moderate to severe renal impairment
  -  Uncontrolled diabetes
  -  Inability to swallow tablets

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

Clinical trial: Genetic Analysis of Familial Melanoma

Summary: In collaboration with members of The International Melanoma Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Detailed description: In collaboration with members of The International Melanoma Genetics Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2A), or the cyclin-dependant kinase 4 (CDK4) genes. CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Eligibility: -  INCLUSION CRITERIA:
  Inclusion into this study was restricted to families containing at least three CMM cases with DNA available for genotyping, and CDKN2A and CDK4 involvement and had been excluded.
  All families must be mutation negative for both CDKN2A and CDK4.
  This study will also include families with at least one case of ocular and two cases of other cutaneous melanomas, or at least 2 ocular melanomas (except where they occur in parent and child).
  EXCLUSION CRITERIA:
  Any family showing evidence of haplotype sharing in the 9p21-p22 region, where CDKN2A is located, was also excluded.

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

Clinical trial: Changes in Muscle Tissue in Patients With Pancreatic Cancer

Summary: RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.
  PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Demonstrate a decrease/increase of fat-free mass (FFM) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Determine the correlation between changes in FFM and 6-month survival.
  -  Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Collect adjuvant information, such as weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count, in these patients.
  OUTLINE: This is a pilot study.
  Patients will have weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing.
  Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
  PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-3
  -  Must be able to stand unassisted on a scale
  -  Must not have pacemaker or implanted defibrillator
  PRIOR CONCURRENT THERAPY:
  -  Prior chemotherapy or radiotherapy allowed
  -  No concurrent use of any of the following:
  -  Corticosteroids
  -  Steroids as anti-emetics associated with chemotherapy allowed
  -  Anabolic steroids
  -  Thalidomide
  -  Megesterol
  -  Eicosapentaenoic acid (EPA)
  -  Nutritional supplements without EPA allowed
  -  Juven
  -  Concurrent enrollment in other clinical trials allowed

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

Clinical trial: AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Summary: The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.


Eligibility: Inclusion Criteria:
  -  Confirmed with pancreatic cancer
  -  Have failed first line gemcitabine therapy
  Exclusion Criteria:
  -  Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
  -  Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.

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

Clinical trial: Zinc Supplements in Lowering Cadmium Levels in Smokers

Summary: RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage.
  PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.

Detailed description: OBJECTIVES:
  -  Determine whether zinc supplements reduce cadmium levels in smokers.
  -  Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits.
  -  Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula.
  -  Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair.
  -  Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair.
  OUTLINE: This is an open-label, nonrandomized study.
  Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity.
  Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis.
  After completion of study therapy, patients are followed for 5 weeks.

Eligibility: DISEASE CHARACTERISTICS:
  -  Currently smoking ≥ 1 pack (20 cigarettes) per day
  -  Baseline cadmium level ≥ 0.5 μg/L
  PATIENT CHARACTERISTICS:
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No known gastrointestinal upset due to zinc vitamins or lozenges
  PRIOR CONCURRENT THERAPY:
  -  At least 2 weeks since prior and no other concurrent vitamins and zinc supplements

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

Clinical trial: EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Summary: The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.


Eligibility: Inclusion Criteria:
  -  Inoperable adenocarcinoma of the pancreas
  -  Histologic or cytologic confirmation
  -  At least 18 years of age
  Exclusion Criteria:
  -  Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
  -  Major surgery within 4 weeks prior to enrollment
  -  Major cardiovascular 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: Outcome of Pancreatic Stump Closure Following Resection of Tumors of the Head of the Pancreas.

Summary: Chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.


Eligibility: Inclusion Criteria:
  -  Pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy.
  Exclusion Criteria:
  -  Patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma)
  -  Charts not available for review.

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

Clinical trial: Proteomic Analysis of HLA Complex in Solid Cancers: Breast, Ovary, Colon, Rectum, Stomach, and Pancreas

Summary: The purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

Detailed description: The main objective of the study is to evaluate which proteins are presented by the HLA complex of solid tumors. Secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. Real specimens will be evaluated using PCR and mass spectrometry.

Eligibility: Inclusion Criteria:
  -  Patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas
  Exclusion Criteria:
  -  Withdrawal of consent
  -  Small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation

Relevance to patient case: not relevant