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NCT02750657Completed

Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection

Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinomas (PDAC) for Better Treatment Selection: A Prospective Study

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Status (registry)
Completed
Study type
Observational
Enrollment
332 (actual)
First submitted
19 Jan 2016
Start date
1 Dec 2015
Primary completion date
31 Aug 2025
Lead sponsor
University Health Network, Toronto
NCT number
NCT02750657

What you commit to

  • Study type: Observational
  • Participants enrolled: 332
  • From 1 Dec 2015 to the primary completion date, 31 Aug 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
  • Patients who are currently on anti-cancer treatment including chemotherapy.
  • Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.

Other illness

  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Other

  • Patients with one or more contraindications to tumor biopsy.
  • Patients with known brain metastases.

Who the study is looking for

  • Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
  • Patient must have a tumor lesion that is amenable to a core needle biopsy.
  • Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
  • Patients must be fit enough to safely undergo a tumor biopsy.
  • Age 18 years or older.
  • Eastern Cooperative Group (ECOG) performance status of 1 or less.
  • Life expectancy of greater than 90 days.
  • Patients must have normal organ and marrow function
  • Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
  • Ability to understand and willing to sign a written informed consent document.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kingston Health Sciences Centre
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.