araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response

Summary: Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells. Investigators at The University of Michigan are conducting a research project, to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy.

Detailed description: Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells.Each patient is unique in terms of the cancer type and location and its sensitivity to treatments. Investigators at The University of Michigan are conducting a research project to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy. Each patient is unique in terms of the cancer type and location and its sensitivity to treatments.

Eligibility: Inclusion Criteria:
  -  Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy followed by surgical resection.
  -  Patients must be >18 years old.
  -  Patients cannot weight over 300 pounds, the weight limit of the MRI table.
  -  Patients must have adequate renal function (estimated glomerular filtration rate > 60 mL/min/m2), to minimize the small risk of nephrogenic systemic sclerosis associated with gadolinium injection.
  -  Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of UM hospital.
  Exclusion Criteria:
  -  Patients must have no previous radiation to the abdomen.
  -  Patients who are pregnant or lactating are excluded.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

Summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  metastatic pancreatic cancer (adenocarcinoma);
  -  good liver, kidney, and bone marrow function.
  Exclusion Criteria:
  -  previous systemic treatment for metastatic pancreatic cancer;
  -  pregnant or lactating females;
  -  fertile men, or women of childbearing potential, not using adequate contraception;
  -  major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
  -  current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Using Videos in Advance Care Planning for Patients With Advanced Cancer

Summary: To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.

Detailed description: A.1. Aim 1: To recruit 150 subjects with advanced cancer and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting CPR (intervention) or 2. a verbal narrative describing the CPR.
  Hypothesis 1: It is feasible to recruit and randomize 150 subjects with advanced cancer.
  A.2. Aim 2: To compare the care preferences for CPR among 150 subjects randomized to video vs. verbal narrative intervention.
  Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt NOT to have CPR compared to those randomized to the verbal narrative.
  A.3. Aim 3: To compare knowledge assessment of CPR for 150 subjects randomized to video vs. verbal narrative intervention.
  Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

Eligibility: Inclusion Criteria:
  1. diagnosis of cancer that falls under one of the following: A. All patients with brain cancer, inoperable hepatocellular/bile duct/gallbladder cancer, incurable non-small cell lung carcinoma (wet IIIb or IV), extensive stage small cell lung cancer, inoperable mesothelioma, inoperable pancreatic cancer or; metastatic gastric or esophageal cancer, metastatic melanoma, OR B. Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma, OR C. Less than one year prognosis.
  2. ability to provide informed consent,
  3. cognitive ability to participate in the study
  4. ability to communicate in English.
  Exclusion Criteria:
  1. inability to make decisions,
  2. non-English speaking,
  3. new patient visit

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Nerve Growth Factor in Chronic Pancreatitis

Summary: This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.
  Hypothesis:
  1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
  2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.


Eligibility: Inclusion Criteria:
  -  Patients with established CP and none of the exclusion criteria mention below.
  Exclusion Criteria:
  -  Failure to obtain consent.
  -  Any comorbid condition with expected survival < 1 year.
  -  Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.
  -  Patients < 18 years of age at time of consent

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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