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

Clinical trial: A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer.
  Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days.
  Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics.
  Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination.
  -  Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC
  -  Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer
  -  Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer


Eligibility: Inclusion Criteria:
  -  histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement.
  -  Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply.

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

Clinical trial: Registry Study - Whipple at the Splenic Artery

Summary: The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).

Detailed description: Primary
  The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are
  -  To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
  -  To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
  Secondary
  The secondary objectives of this registry study are to
  -  To determine the survival/recurrence rates at 2 years.
  -  To determine the effect of occlusion of the splenic vein at the confluence.

Eligibility: Eligibility Criteria - Prospective Portion:
  -  Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
  -  Patient must be between 18 to 85 years of age.
  -  Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
  -  Patient must be able to understand and willing to sign a written informed consent document.
  Eligibility Criteria - Retrospective Portion:
  Patient underwent WATSA procedure at our institution between 01/01/2009 and 12/31/2011.

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/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

Summary: The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.
  The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

Detailed description: The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.

Eligibility: Inclusion Criteria:
  1. Adults (≥ 18 years) at the time of signing informed consent form
  2. Understand and voluntarily sign informed consent form
  3. Able to adhere to study visit schedule and other protocol requirements
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  5. Absolute neutrophil count ≥ 1500 / mm³
  6. Platelet count ≥ 100,000 / mm³
  7. Resectable pancreatic adenocarcinoma
  8. Pathologic diagnosis of pancreatic adenocarcinoma
  Exclusion Criteria:
  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
  2. A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
  3. Presence of active infection
  4. Untreated second malignancy
  5. Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of 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: A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer

Summary: The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.

Detailed description: Following first-line therapy with a gemcitabine based regimen, a significant number of patients will maintain an adequate performance status and be able to tolerate a second-line therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The interim results showed a statistically significant survival advantage for the oxaliplatin containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have progressed on a first-line gemcitabine regimen is still poor with median survival of about 2-6 months.
  Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit progression and /or toxicity and will require second line therapy at 4-6 months into first line therapy. The best one year survival reported in a phase II trial is only 24%. However there is no standard second line therapy for APC, a rapid progression of tumor is seen in this setting, and new strategies based on rational target identification are needed. In this study we propose to select therapy based on the molecular profiling of each patients tumor.

Eligibility: Inclusion Criteria:
  -  metastatic adenocarcinoma of the pancreas
  -  male or non-pregnant female
  -  18 years of age or greater
  -  one prior therapy for the treatment of metastatic disease
  -  must start continuation therapy within 9 months of starting first line treatment
  -  have adequate organ and bone marrow function
  -  must have a Karnofsky performance status greater than or equal to 70
  -  one or more metastatic tumors measurable by CT scan and accessible for biopsy
  Exclusion Criteria:
  -  operable or locally advanced pancreatic cancer
  -  metastatic tumor that is not amendable to biopsy
  -  known brain mets unless previously treated and well controlled
  -  active, uncontrolled bacterial, viral or fungal infections
  -  known infection with HIV, hepatitis B or hepatitis C
  -  pregnant or breast-feeding patients

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

Clinical trial: Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

Summary: The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.

Detailed description: Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
  -  Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
  -  Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
  -  Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) —OR— Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.
  Exclusion Criteria:
  -  Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
  -  Positive surgical margins.
  -  Lack of clinical followup at one year following surgery

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

Clinical trial: BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency

Summary: 13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.

Detailed description: The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.

Eligibility: Inclusion Criteria:
  1. Patients with chronic pancreatitis who meet at least one of the following criteria:
  -  Adult men or women >18 years of age.
  -  Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
  -  Abnormal secretin pancreatic function test with a peak bicarbonate concentration <80 mEq/L
  -  Presence of pathogenomic pancreatic calcifications
  -  Pathology proven chronic pancreatitis on surgical specimens
  2. Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
  3. Patients who can fast for at least 8 hours
  4. Able to perform the testing and procedures required for the study, as judged by the investigator
  5. Willing and able to provide written informed consent
  Exclusion Criteria:
  -  Failure to obtain consent
  -  Patients with liver cirrhosis
  -  Any co-morbid condition with expected survival < 1 year
  -  History of extensive bowel resection, multiple abdominal surgeries
  -  Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
  -  Uncontrolled diabetes
  -  Patients currently receiving total parenteral nutrition (TPN)
  -  Recipients of an organ transplant
  -  Patients who have consumed >20cc of alcohol or have taken acetaminophen in the past 24 hours
  -  History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
  -  Patients taking drugs that can interfere with 13C di-peptide metabolization

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

Clinical trial: HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Summary: The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.

Detailed description: The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Eligibility: Inclusion Criteria:
  -  locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  -  Measurable disease by CT scan
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  laboratory values as follows: 2,000/mm3 < WBC < 15,000/mm3, Platelet count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
  -  HLA-A*0201
  -  Able and willing to give valid written infromed consent
  Exclusion Criteria:
  -  Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  -  Breast-feeder
  -  Active or uncontrolled infection
  -  Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  -  Serious or uncured wound
  -  Active or uncontrolled other malignancy
  -  Steroids or immunosuppressing agent dependent status
  -  Interstitial pneumonia
  -  Ileus
  -  Decision of unsuitableness by principal investigator or physician-in-charge

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

Clinical trial: P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

Summary: P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.
  The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.
  following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.
  Blocks from endometrioid endometrial cancer will be used as a control group.


Eligibility: Inclusion Criteria:
  -  diagnosis of endometrial cancer
  -  histology block exists in hospital's library
  Exclusion Criteria:

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

Clinical trial: Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

Summary: No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Detailed description: Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility: Inclusion Criteria:
  -  Diagnosis of pancreatic cancer
  -  Preoperative chemotherapy
  -  Pancreatic resection
  Exclusion Criteria:
  -  Metastatic disease
  -  ASA score 4

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

Clinical trial: Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas

Summary: This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.

Detailed description: Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.

Eligibility: Inclusion Criteria:elective surgery patients undergoing pancreatoduodenectomy
  -  soft pancreas, no dilated duct
  Exclusion Criteria:
  -  age > 75 years old
  -  documented chronic pancreatitis
  -  previous pancreatic surgery
  -  previous gastric surgery vagotomy
  -  documented pancreatic duct dilatation

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

Clinical trial: Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Summary: The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

Detailed description: Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer.
  The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.
  The objectives are:
  • To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Eligibility: Inclusion Criteria:
  -  Either gender greater than or equal to 18 years of age.
  -  Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
  -  Biliary obstruction
  -  Blocked self expanding mesh metal stent (SEMS)
  -  Subjects capable of giving informed consent
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Cardiac Pacemaker
  -  Patient unstable for endoscopy
  -  Inability to give informed consent
  -  Uncorrected coagulopathy

Relevance to patient case: not relevant