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

Clinical trial: CTC Pancreatic Adenocarcinoma

Summary: Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)

Detailed description: This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.

Eligibility: Inclusion Criteria:
  -  Age 18 to 85
  -  ASA I-III ( American Society of Anesthesiologists)
  -  Resectable pancreatic adenocarcinoma
  -  Primary surgery
  -  No neoadjuvant therapy
  -  Written informed consent
  Exclusion Criteria:
  -  Metastatic disease
  -  Other than primary surgery (recurrence, reconstruction)
  -  Pre-operative chemotherapy
  -  Chronic opioid use
  -  Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
  -  Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
  -  Pregnancy
  -  Breast feeding
  -  Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

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

Clinical trial: Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

Summary: This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
  -  Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
  -  Anticipated life expectancy ≥ 12 weeks
  -  Radiographically measurable disease acc. to RECIST 1.1
  -  Use of adequate contraception (as described in protocol)
  -  Ability to provide written informed consent and comply with study requirements
  Exclusion Criteria:
  -  Received other cancer treatment or investigational drug within 4 weeks prior to screening
  -  Women who are pregnant or breastfeeding
  -  Had major surgery within 4 weeks of first dose of study drug
  -  Inadequate liver, renal or bone marrow function within 2 weeks of first dose
  -  Serious concurrent illness, altered medical status or any uncontrolled medical condition
  -  Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
  -  Known active HIV, HBV or HCV infection
  -  Inability to swallow tablets
  -  History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation

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

Clinical trial: Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Summary: The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.


Eligibility: Inclusion Criteria:
  -  Surgeon trained in and performing the HIPEC procedure
  Exclusion Criteria:
  -  Not performing the HIPEC procedure

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

Clinical trial: In Vitro Models of Liver and Pancreatic Cancer

Summary: The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the investigators hope to compare molecular and cellular biology of cancer cells with normal cells as well as potentially test the efficacy of current and future anti-cancer therapies.
  Samples will be collected from tissue that has been resected as part of the treatment for a patient diagnosed with liver, bile duct or pancreas cancer.


Eligibility: Inclusion Criteria:
  -  All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.
  Exclusion Criteria:
  -  Patients aged <18 or those who are unable to give informed consent.

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

Clinical trial: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Summary: This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  -  Stage IV disease diagnosed within 6 weeks of randomization
  -  Adequate hematologic function:
  -  Absolute neutrophil count (ANC) ≥1.5 x 109/L
  -  Platelet count ≥100 x 109/L
  -  Hemoglobin ≥9 g/dL
  -  Adequate hepatic and renal function defined as:
  -  AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  -  Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
  -  Estimated Creatinine Clearance ≥30 mL/min
  -  KPS ≥70.
  -  Eastern Cooperative Oncology Group (ECOG) 0-1
  Exclusion Criteria:
  -  Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
  -  Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
  -  Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
  -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  -  Major surgery within 4 weeks of first dose of study drug.
  -  Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.

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

Clinical trial: According CTC to Compare the Influences of Different Methods to Remove the PDAC

Summary: Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.


Eligibility: Inclusion Criteria:
  -  Ductal adenocarcinoma of pancreatic body and tail
  -  Tumor can be removed
  -  No other tumors and without liver metastases
  -  Age from 18 to 80 years old
  Exclusion Criteria:
  -  Neoplasms with other sites of the pancreas
  -  With other tumors of any other sites

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

Clinical trial: Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI

Summary: The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.


Eligibility: Inclusion Criteria:
  -  BRCA 1 or 2 mutation
  -  Age ≥ 30
  -  Patients scheduled to undergo screening breast MRI with contrast
  Exclusion Criteria:
  -  Patients with known breast cancer
  -  Patients unable to complete their scheduled breast MRI
  -  Patients with prior pancreatic surgery or cancers
  -  Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
  -  Patients with prior abdominal or pelvic surgery

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

Clinical trial: Screening for PDAC in BRCA1/2 Patients

Summary: The study is a prospective, observational, case-control study evaluating the utility of endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2 mutations.


Eligibility: Inclusion Criteria:
  -  Informed consent provided
  -  Age greater than or equal to 18
  Patients:
  -  Able and willing to attend routine follow-up as advised BRCA2 Mutation Carriers
  -  Patients with a history of BRCA2 Mutation, with or without manifestation of breast or ovarian cancer, over the age of 50.
  -  Any BRCA2 patient who has a first degree or 2 second degree family members with a history or pancreatic cancer will initiate screening 10 years prior to the age of onset of the index pancreatic neoplasia. BRCA1, ATM, & PALB2 Mutation Carriers
  -  Any BRCA1 patient who has a first degree or 2 second degree family members with a history or pancreatic cancer will initiate screening 10 years prior to the age of onset of the index pancreatic neoplasia.
  Exclusion Criteria:
  -  Known infection with HIV, HBC, or HCV
  -  Pregnancy Esophageal strictures prior to treatment
  -  Zenkers Diverticulum prior to treatment
  -  History of abnormal or post surgical (i.e. post-Roux-en-Y Gastric Bypass) foregut anatomy precluding endoscopic ultrasound examination of the pancreas.

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

Clinical trial: Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Summary: This is an open-label, phase 2 comparative study to assess the safety, tolerability, and efficacy of nal-IRI in combination with other anticancer therapies, compared to nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy. This study will assess the following regimens:
  -  nal-IRI + 5-FU/LV + oxaliplatin
  -  nal-IRI + 5-FU/LV
  -  nab-paclitaxel + gemcitabine
  The study will be conducted in two parts:
  1. a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and
  2. a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV, versus nab-paclitaxel + gemcitabine.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed adenocarcinoma of the pancreas not previously treated in the metastatic setting
  Part 1: Unresectable, locally advanced or metastatic disease; diagnosed within 6 wks prior to enrollment; Part 2: Metastatic disease; diagnosed within 6 wks prior to randomization
  -  Measurable or non-measurable disease as defined by RECIST v1.1
  -  ECOG performance of 0 or 1
  -  Adequate hematological, hepatic, renal and cardiac function
  Exclusion Criteria:
  -  Prior treatment of pancreatic cancer in the metastatic setting with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
  -  Prior treatment of pancreatic cancer with chemotherapy (radiation sensitizer allowed if ≥ 6 months has elapsed from completion)
  -  Uncontrolled CNS metastases
  -  Clinically significant gastrointestinal disorder
  -  History of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible
  -  Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin, oxaliplatin, nab-paclitaxel (part 2 only) or gemcitabine (part 2 only)
  -  Use of strong CYP3A4 or CYP2C8 inhibitors or inducers (part 2 only)
  -  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: Treatment of Pancreatic Cancer With Abraxane

Summary: This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

Detailed description: This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
  A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
  Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.

Eligibility: Inclusion Criteria:
  1. Metastatic pancreatic carcinoma
  2. Age > 18 years
  3. Signed Informed Consent
  4. Normal hepatic, renal and Bone Marrow functions
  Exclusion Criteria:
  1. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils < 1,5 x 10^9/L

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

Clinical trial: Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III

Summary: After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.
  The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Male or female, age superior to 18 years.
  -  Histologically confirmed colonic or rectal adenocarcinoma.
  -  stage II or III (TNM classification).
  -  Curative resection (R0)
  -  Absence of metastasis (abdominal ultrasonography or CTscan and pulmonary Rx or CTscan) in exams performed within 4 weeks.
  -  ECOG performance status <3.
  -  Signed and dated informed consent document.
  Exclusion Criteria:
  -  Metastatic disease.
  -  Familial adenomatous polyposis
  -  Prior chemotherapy and or radiotherapy within 6 weeks
  -  Medical history of cancer within 5 years except: basocellular cutaneous neoplasia and intraepithelial neoplasia of the cervix

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

Clinical trial: Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Summary: Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Detailed description: Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
  All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
  All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
  After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
  Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
  Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Eligibility: Inclusion Criteria:
  -  Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
  -  Fitness for chemotherapy in judgement of treating physician
  -  Bilirubin < 4 (any means of biliary drainage acceptable)
  Exclusion Criteria:
  -  Medical or mental illness precluding provision of informed consent
  -  Pregnancy
  -  Active infection for which neutropenia would pose high risk of mortality

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

Clinical trial: Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

Summary: Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Detailed description: Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

Eligibility: Inclusion Criteria:
  Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)
  Exclusion Criteria:
  Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

Relevance to patient case: not relevant