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

March 21, 2025 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) rate
Time Frame: Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) rate
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy
Up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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