Prognostic and Predictive Markers of Treatment Response in Patients With PAC. (CANOPE)

Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Adenocarcinoma

Detailed Description

The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.

The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

• Study Type: Observational
• Enrollment (Estimated): 4050

Contacts and Locations

• Study Contact: Name: Angelique VIENOT, MD; Phone Number: 01402985 00; Email: regulatory.Affairs@gercor.com.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU Jean Minjoz
    • Contact: Angélique VIENOT, MD
    • Principal Investigator: Angélique Vienot, MD
  • Clichy, France
    • Recruiting
    • Hôpital Beaujon
    • Contact: Louis DE MESTIER, MD
  • Créteil, France
    • Not yet recruiting
    • CHU - Henri Mondor
    • Contact: Christophe TOURNIGAND, MD
  • Lille, France
    • Recruiting
    • CHU Lille
    • Contact: Anthony TURPIN, MD
  • Lyon, France
    • Not yet recruiting
    • Centre Leon Berard
    • Contact: Pauline ROCHEFORT, MD
  • Nancy, France
    • Recruiting
    • HRU Nancy Site Brabois
    • Contact: Marie MULLER, MD
  • Paris, France
    • Not yet recruiting
    • Institut Mutualiste Montsouris
    • Contact: David MALKA, MD
  • Paris, France
    • Recruiting
    • Hôpital Saint Antoine
    • Contact: Antoine DARDENNE
  • Paris, France
    • Recruiting
    • Hopital Georges Pompidou
    • Contact: Jeanne NETTER, MD
  • Poitiers, France
    • Not yet recruiting
    • CHU Poitiers
    • Principal Investigator: David TOUGERON, MD
    • Contact: David TOUGERON, MD
  • Reims, France
    • Not yet recruiting
    • Chu Reims
    • Contact: Olivier BOUCHE, MD
  • Rennes, France
    • Not yet recruiting
    • CHU Pontchaillou
    • Principal Investigator: Astrid LIEVRE, MD
    • Contact: Astrid LIEVRE, MD
  • Saint-Cloud, France
    • Not yet recruiting
    • Institut Curie
    • Contact: Cindy NEUZILLET, MD
  • Strasbourg, France
    • Not yet recruiting
    • IHU - Institut de chirurgie guidée par l'imagerie
    • Contact: Julieta MONTANELLI, MD
  • Villejuif, France
    • Recruiting
    • Hôpital Paul Brousse
    • Contact: Pascal Hammel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Retro-prospective (diagnosis between 2003 and 2022) and prospective (diagnosis between 2023 and 2030) cohorts of patients with pancreatic adenocarcinoma

Description

Inclusion Criteria:

• Patient with histologically confirmed pancreatic adenocarcinoma.
• Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery
• Diagnosis between January 1, 2003, and December 31, 2030.
• First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.
• Age ≥ 18 years.
• Written informed consent

Exclusion Criteria:

• Patient under guardianship, curatorship, or judicial protection.
• Pregnant or breastfeeding women.
• Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.
• Refusal to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) rate	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of death regardless of the cause. Living or lost to follow-up patients will be censored at the date of the last news	Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) rate	Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of first progression or date of death regardless of the cause. Living patients without progression or lost to follow-up will be censored at the date of the last news	Up to 7 years
Number of patient with objective response rate	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Number of patient with stability rate	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Number of patient with tumor progression	Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Number of patient with grade 3/4 treatment-related toxicities	Toxicity rates according to CTCAE v5.0 classification. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments.	Up to 7 years
Number of patients who received maintenance treatment in the first-line	Study the profiles of patients receiving maintenance treatment in 1st-line chemotherapy	Up to 7 years
Number of patients who received second and third-line treatments	Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy	Up to 7 years

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Principal Investigator: Angelique VIENOT, MD, CHRU de Besançon - Institut Régional Fédératif du Cancer (IRFC) de Franche-Comté; Principal Investigator: Anthony Turpin, MD, Hôpital Claude-Huriez

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: CANOPE GB-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No