araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Summary: Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

Detailed description: This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
  The specific aims of this subproject include:
  1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
  2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
  3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
  4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
  5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

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: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

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: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

Summary: The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

Detailed description: -  Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
  -  Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
  -  Participants will remain on the study as long as they continue to benefit from the study medication.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of pancreatic adenocarcinoma
  -  18 years of age or older
  -  At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
  -  Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
  -  Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
  -  Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
  -  ECOG performance status 0-1.
  -  Life expectancy of greater than 12 weeks.
  -  Adequate bone marrow and liver function.
  -  Must be able to swallow tablets.
  Exclusion Criteria:
  -  Prior treatment with an investigational drug within the preceding 4 weeks.
  -  Prior treatment with an inhibitor of mTOR
  -  Chronic treatment with systemic steroids or another immunosuppressive agent
  -  More than one prior chemotherapy treatment for metastatic disease
  -  Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
  -  Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  -  Patients with chronic renal insufficiency
  -  Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
  -  Known history of HIV seropositivity
  -  Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
  -  Active, bleeding diathesis or an oral vitamin K antagonist medication
  -  Women who are pregnant or breast feeding

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

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: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

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
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Summary: Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description: Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility: Inclusion Criteria:
  -  Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
  -  The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
  Exclusion Criteria:
  -  Non consent.
  -  The patients' general condition will not tolerate either treatment (strategy).
  -  Previous laparotomy or laparoscopy.
  -  Life expectancy < 3 months.
  -  Inability to participate (language, social, etc.)

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Summary: A dose finding study in locally advanced and/or metastatic pancreatic cancer patients


Eligibility: Inclusion criteria:
  1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
  2. Adequate bone marrow, liver and renal function on everolimus treatment
  3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
  4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
  5. Age >18 years
  Exclusion criteria:
  1. Women who are pregnant or breast feeding.
  2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
  3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
  4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
  5. Chronic treatment with systemic steroids or another immunosuppressive agent
  6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
  7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value < 50 % or prothrombine time more than 1,5 fold higher
  Other protocol defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Clinical Outcomes in Hereditary Cancer

Summary: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
  Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Detailed description: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
  Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Eligibility: Inclusion Criteria:
  -  Included in DB0363-03
  -  Jewish religious preference at registration
  -  Archival material available for testing
  -  Adequate post-surgical follow-up
  -  Jewish religious preference at registration
  -  Archival material available for testing
  -  Adequate follow-up to determine time to progression
  Exclusion Criteria:
  -Subjects will not be included in the analyses if a DNA sample cannot be obtained.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Summary: There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
  -  To determine safety
  -  To determine overall survival
  -  To determine time to progression

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  At least one measurable lesion according to RECIST criteria that has not been irradiated
  -  Adequate laboratory parameters as outlined in protocol
  -  Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
  -  Negative serum pregnancy test within 14 days prior to registration
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Life expectancy < 3 months
  -  Serious, uncontrolled, concurrent infection(s)
  -  Any prior oxaliplatin or fluoropyrimidine therapy
  -  More than one prior chemotherapy regimen for unresectable or metastatic disease
  -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
  -  Any active second malignancy
  -  Clinically significant cardiac disease or myocardial infarction within the last 12 months
  -  Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
  -  Other serious uncontrolled medical conditions
  -  Major surgery within 4 weeks of the start of study treatment, without complete recovery
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  -  Known, existing uncontrolled coagulopathy

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: CT Pancreas Perfusion

Summary: 1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
  2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
  3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.


Eligibility: Inclusion Criteria:
  1. a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
  2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).
  2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
  2c. To answer pain questionnaire before first CT perfusion scan.
  2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
  3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
  3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.
  Exclusion Criteria:
  1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.
  1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
  2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
  3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .
  Any Cohort:
  4. Pregnant.
  5. Prior iodine contrast reactions.
  6. Iodine allergy.
  7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
  8. Any contraindication to having a CT scan with iodine contrast.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

Summary: Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Detailed description: Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.
  ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.
  Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.
  Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.
  Statistical analysis:
  -  Common closing date: 1/11/2007
  -  Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
  -  Cox logistic regression (uni/multivariate)

Eligibility: Inclusion Criteria:
  -  DPAC
  -  Primary resection
  Exclusion Criteria:
  -  Positive section margins
  -  non DPAC, other tumor
  -  Postoperative mortality
  -  Neoadjuvant chemo/radiotherapy

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Tight Glycemic Control by Artificial Pancreas

Summary: This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Detailed description: This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Eligibility: Inclusion Criteria:
  -  This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
  Exclusion Criteria:
  -  weight loss greater than 10% during the previous 6 months
  -  signs of distant metastasis
  -  respiratory, renal,or heart disease
  -  Patients provided written informed consent prior to enrollment

Relevance to patient case: not relevant