araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: The Registration Program of BRCA1/2 Gene

Summary: Purpose:
  1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
  2. To build the breast cancer BRCA1/2 mutation database of Chinese group.
  3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

Detailed description: It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.

Eligibility: Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).
  The selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).
  Inclusion Criteria:
  Patients: it must be from independent family and meet the one or more of the following conditions.
  1. Patients' age at diagnosis: 45 years or younger.
  2. Patients' age at diagnosis: 50 years or younger.
  3. Breast cancer patients: it must meet the one or more of the following family medical histories.
  3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.
  3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.
  3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.
  3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.
  3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading＞7, any of age).
  3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.
  4. Triple negative patients' age of onset: 60 years or younger.
  5. Patients: male and have breast cancer.
  Patients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):
  First or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.
  First or second degree male relatives of patients have breast cancer.
  Exclusion Criteria:
  N/A.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis

Summary: It is important to identify patients with acute pancreatitis who are at risk for developing persistent organ failure early in the course of disease. The investigators evaluated whether peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could serve as a good marker for detection of acute pancreatitis with persistent organ failure at early phase.

Detailed description: Acute pancreatitis is a sudden inflammation of the pancreas. It can have severe complications and high mortality despite treatment. While mild cases are often successfully treated with conservative measures, such as fasting and aggressive intravenous fluid rehydration, severe cases may require admission to the intensive care unit or even surgery to deal with complications of the disease process. The diagnosis of severe acute pancreatitis at an early phase remain a major challenge for clinicians.
  Therefore, many biologic markers have been studied in an effort to improve the diagnostic rate and determine the severity of acute pancreatitis but with disappointing results. Non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), have recently been validated to stably exist in peripheral blood. Several publications showed that it may serve as potential markers for various diseases, including cancer and inflammation. Our current study evaluated whether and which kind of non-coding RNAs could serve as good markers for severe acute pancreatitis.

Eligibility: Inclusion Criteria:
  -  Patients who was diagnosed acute pancreatitis
  -  Male or female
  -  18 Years and older
  -  written informed consent
  Exclusion Criteria:
  -  Symptoms of acute pancreatitis present for more than 72 hours
  -  Age under 18 years
  -  Pregnancy
  -  patients unable to consent

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement

Summary: The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.


Eligibility: Inclusion Criteria:
  -  Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy).
  -  At least 18 years of age.
  -  Able to read and understand English (the SAFECARE at Home program is only implemented in English)
  -  Has internet access.
  -  Knowledge of the internet and how to use web-based programs.
  -  Not pregnant or breastfeeding.
  -  Able to understand and willing to sign an IRB-approved written informed consent document.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Summary: The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.


Eligibility: Inclusion Criteria:
  -  All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.
  -  Age 18 - 80 years old
  -  American Society of Anesthesiologist (ASA) class I - III
  -  BMI < 40
  -  Ability to understand and read English
  Exclusion Criteria:
  -  Not able or willing to sign consent
  -  Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).
  -  History of epilepsy or currently receiving treatment for seizures
  -  Severe hepatic insufficiency (Child-Pugh Score C)
  -  Renal insufficiency (creatinine clearance less than 30 mL/minute)
  -  Advance heart failure (NY Heart failure stage 3 or greater; Ejection function <30%)
  -  Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
  -  Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate
  -  Patients with active psychiatric disorders or cognitive dysfunction
  -  Pregnancy or lactating
  -  Enucleation, central, and distal pancreatectomy
  -  Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Women at Risk of Breast Cancer and OLFM4

Summary: Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

Detailed description: About 5% of breast cancers are associated with the presence of a constitutional genetic alteration. Two genes are being studied: BRCA1 and BRCA2.
  The national program for breast cancer screening target women 50 to 74 years but does not include women with significant risk factors. However in identifiable risk situations, breast cancer incidence is increased: and it affects 1 in 4 women with certain risk histological lesions and more than 1 in 2 women carrying a mutation in the BRCA1 or BRCA2 gene.
  Studies have shown that the olfactomédine 4 (OLFM4) is highly overexpressed in tumors compared to healthy tissue. The OLFM4 might therefore be a marker for early detection of breast cancer. We wish to determine the positive predictive value of OLFM4 seric dosing of patients at risk with respect to imaging.

Eligibility: Inclusion Criteria:
  -  Age > or = 18 years
  -  High risk women of breast cancer occurrence defined by the following criteria:
  -  Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM
  -  Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists
  -  Information of the person and signing the informed consent
  Exclusion Criteria:
  -  Women with a history of breast cancer or in situ
  -  Person who is not affiliated to a social security scheme or beneficiary of such a regime

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation

Summary: Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.


Eligibility: Inclusion Criteria :
  -  Older than 18 or parental agreement in case of children.
  For patient with early-onset breast cancer :
  -  Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
  -  Sporadic or familial presentation
  -  No genomic alterations of BRCA1, BRCA2 or TP53
  For patient with early-onset ovarian cancer :
  -  Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
  -  Sporadic or familial presentation
  -  No genomic alterations of BRCA1, BRCA2
  Patient with early-onset colorectal cancer :
  -  Invasive colorectal cancer diagnosed before 31 years.
  -  Sporadic or familial presentation
  -  No genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
  -  No genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation
  Patient with pediatric cancer :
  -  Non haematological tumour diagnosed before 16 years, with Li-Fraumeni presentation.
  -  No genomic alteration of TP53
  Patient with Multiple primary malignant tumours :
  -  Multiple synchronous or metachronous primary malignant tumors with early-onset
  -  No syndromic presentation
  Exclusion Criteria:
  -  Any already known deleterious mutations according to the patient's phenotype

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

Summary: Various centers around the world are currently investigating the feasibility and yield of surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to accumulate that surveillance may lead to the early detection of non-invasive precursor lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to reduce mortality in these high risk individuals, but before this can be confirmed many research questions need to be answered. While the numbers of high-risk individuals screened in each separate screening facility are likely too small to properly address many of these questions, pooling data comprises a sizable sample size providing unique research opportunities. The objective of this study is retrospectively review all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

Detailed description: The study is a retrospective review of all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

Eligibility: Inclusion Criteria:
  -  Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas

Summary: Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.

Detailed description: The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.

Eligibility: Inclusion Criteria:
  1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
  2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
  3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
  4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
  5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
  -  Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  -  Platelet count ≥ 100,000/mm3 (100 × 10^9/L)
  -  Hemoglobin (Hgb) ≥ 9 g/dL.
  6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
  -  AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
  -  Total bilirubin ≤ULN
  7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
  8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
  Exclusion Criteria:
  1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  2. Patients have uncontrolled bacterial, viral, or fungal infections
  3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
  4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
  5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
  6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

Summary: This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Overall survival (OS) (18 to 27 months after resection).
  SECONDARY OBJECTIVES:
  I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage.
  OUTLINE: Patients are randomized to 1 of 3 arms.
  Arm I (EIPL-S) extensive intraoperative peritoneal saline lavage: Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes.
  Arm II (EIPL-D) extensive intraoperative peritoneal distilled water lavage: Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes.
  Arm III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.
  After completion of study treatment, patients are followed up every 3 months.

Eligibility: Inclusion Criteria:
  -  The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
  -  A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
  -  In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
  -  The subject is willing to consent to randomization of lavage vs. standard lavage
  Exclusion Criteria:
  -  The subject does not have a surgical indication for pancreatectomy
  -  In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
  -  The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard
  -  Subject with neoadjuvant chemotherapy or chemoradiation
  -  Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Summary: Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Detailed description: This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Eligibility: Inclusion Criteria:
  -  • Subject signed inform consent
  -  Age > 18 years
  -  Not pregnant or breast feeding
  -  Patient capable of undergoing anesthesia
  -  Patient selected to undergo Whipple procedure or distal pancreatectomy
  -  Patient does not have metastatic disease
  -  Patients will have close margins
  -  No prior radiation therapy to the region for separate cancer
  -  Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  -  Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  -  Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  -  Gemcitabine + nb-paclitaxel
  -  FOLFIRINOX
  -  Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
  -  up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
  Exclusion Criteria:
  -  Not surgical candidate
  -  Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
  -  An IRE candidate (IRE is Percutaneous irreversible electroporation)
  -  Recurrent or previously resected tumors
  -  Documented History of Alcoholism and or drug abuse
  -  Participant in other clinical trials

Relevance to patient case: not relevant