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

NCT02750657 | Completed

• 1 other identifier: COMPASS-001
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

• The feasibility of prospectively identifying subgroups of patients with advanced PDAC who have distinct genomic characteristics for better treatment selection while undergoing 1st-line chemotherapy using next generation sequencing.

  8 weeks

Secondary Outcomes (17)

• Disease control rate achieved by m-FOLFIRINOX

  5 years

• Disease control rate achieved by nab-paclitaxel

  5 years

• Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to m-FOLFIRINOX

  5 years

• Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to nab-paclitaxel.

  5 years

• Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with m-FOLFIRINOX.

  5 years

Study Arms (1)

Patients with advanced pancreatic ductal adenocarcinoma

Genetic: Molecular Profiling

Interventions

Molecular Profiling GENETIC

Whole Genome Sequencing

Patients with advanced pancreatic ductal adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Locally advanced or metastatic pancreatic ductal adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• Patients with one or more contraindications to tumor biopsy.
• 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 known brain metastases.
• Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (4)

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (2)

• Karasinska JM, Topham JT, Kalloger SE, Jang GH, Denroche RE, Culibrk L, Williamson LM, Wong HL, Lee MKC, O'Kane GM, Moore RA, Mungall AJ, Moore MJ, Warren C, Metcalfe A, Notta F, Knox JJ, Gallinger S, Laskin J, Marra MA, Jones SJM, Renouf DJ, Schaeffer DF. Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer. Clin Cancer Res. 2020 Jan 1;26(1):135-146. doi: 10.1158/1078-0432.CCR-19-1543. Epub 2019 Sep 3.

  PMID: 31481506 DERIVED

• Aung KL, Fischer SE, Denroche RE, Jang GH, Dodd A, Creighton S, Southwood B, Liang SB, Chadwick D, Zhang A, O'Kane GM, Albaba H, Moura S, Grant RC, Miller JK, Mbabaali F, Pasternack D, Lungu IM, Bartlett JMS, Ghai S, Lemire M, Holter S, Connor AA, Moffitt RA, Yeh JJ, Timms L, Krzyzanowski PM, Dhani N, Hedley D, Notta F, Wilson JM, Moore MJ, Gallinger S, Knox JJ. Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial. Clin Cancer Res. 2018 Mar 15;24(6):1344-1354. doi: 10.1158/1078-0432.CCR-17-2994. Epub 2017 Dec 29.

  PMID: 29288237 DERIVED

Biospecimen

* Fresh tumor tissue biopsy samples * Archival tumor tissue samples * Whole blood samples * Plasma samples * Serum samples

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jennifer J. Knox, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: April 25, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CA (4)