Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma (CONVERCAP)

April 15, 2026 updated by: Institut Bergonié

Convertases and Pancreatic Cancer. New Therapeutic and Prognostic Approach: Cohort of Patients Treated for Pancreatic Adenocarcinoma (CONVERCAP)

This is a prospective, single-centre, observational study. The analysis of samples of pancreatic tumours and/or metastases taken during biopsy or surgery will lead to the determination of the level of expression of convertases in patients with pancreatic cancer and could be used as an additional prognostic means reinforcing those currently used.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After checking the inclusion criteria and signing the consent form, patients will be pre-selected for the study.

A tumour sample (primary tumour or metastasis) will be taken either during a biopsy or during pancreatic or metastasis surgery.

A blood sample will be taken on the same day as the tumour sample. The inclusion visit will be carried out by the investigating physician and will correspond to the visit when the results of the biopsy or surgery are reported.

Inclusion of the patient will be possible if the tumour sample has been taken, is available, contributory and malignant (diagnosis or confirmation of pancreatic adenocarcinoma) and if the blood sample has been taken and is available.

The patient will be considered to have failed pre-selection if

  • the tumour sample has not been taken or is not available, or
  • the tumour sample/histological result is non-contributory, or
  • the histological result is benign, or
  • the blood sample was not taken or is not available, or
  • the patient refuses to continue the study, or
  • the patient has withdrawn consent, or
  • any other reason preventing inclusion of the patient. Included patients will be treated and followed as usual, with standard radiological follow-up.

For two years after inclusion, the tumour status (first progression) and vital status of the patient (alive, dead or lost to follow-up at the date of the visit) will be collected.

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.
50

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 Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Institut Bergonié, Comprehensive Cancer Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven), whatever the stage of the disease ot the type of treatment proposed (systemic, surgery, radiotherapy, etc.), undergoing a biopsy or a surgery to collect tumor and blood samples.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.

  2. Pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven):

    1. Indication for biopsy of metastasis(es) performed as part of standard care for patients who already have a histologically confirmed diagnosis of pancreatic cancer.
    2. Indication for pancreatic surgery or metastasis(es) carried out as part of standard care for patients with a suspicion of pancreatic cancer on radiological assessment or who already have a confirmed histological diagnosis of pancreatic cancer.
  3. Whatever the stage of the disease.
  4. Whatever the type of treatment proposed (systemic, surgery, radiotherapy, etc.).
  5. Patient who has never received systemic treatment or advanced radiotherapy.
  6. WHO 0-1-2.
  7. Life expectancy > 3 months.
  8. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
  9. Patient affiliated to a social security scheme in compliance with Article 1121-11 of the French Public Health Code.

Exclusion Criteria:

  1. Indication for biopsy for primary diagnosis of pancreatic cancer
  2. No indication for treatment of pancreatic cancer.
  3. Adjuvant/neoadjuvant chemotherapy completed less than 6 months ago in the case of patients with recurrent disease.
  4. Patient already included in the study.
  5. Geographical, social or psychological factors rendering the patient unable to undergo study monitoring and procedures.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CONVERCAP patients

The tumour sample (primary tumour or metastasis) will be taken either during a standard biopsy or during pancreatic or metastasis standard surgery.

Biopsy sampling of metastases is only authorised if the primary histological diagnosis of pancreatic adenocarcinoma has already been proven. If the patient has undergone a biopsy for diagnostic purposes, he/she cannot be included in the study.

The blood sample will be taken on the same day as the tumour sample.
Other: Blood sample
On the same day as the tumour sample is taken (biopsy or surgery), a blood sample of approximately 15 to 20 mL is taken in EDTA-free tubes.

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
Correlation coefficients between level of expression of various convertases on the tumor and immune infiltrate
Time Frame: Inclusion, Day 1

The level of expression of convertase proteins and their substrates (VEGF-C, IGF-1) will be determined on tumor samples at inclusion (healthy tissues, primary cancers and metastases), using qRT-PCR, western blot, ELISA, FACs and/or immunofluorescence as methodology and will be correlated with the following immune parameters, determined by immunofluorescence (including but not limited to): CD8, CD4, NK,Tregs, Macrophages

The analysis will assess the correlation between the expression of various convertases on the tumor and immune parameters using Pearson's correlation coefficient for normally distributed variables, or Spearman's correlation coefficient for non-normally distributed variables. The correlation coefficient ranges from -1 to 1: a value closer to 1 indicates a strong positive association, a value closer to -1 indicates a strong negative association, and a value closer to 0 indicates no association.
Inclusion, Day 1

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
Correlation coefficients between level of expression of various convertases determined at plasma level and immune infiltrate
Time Frame: Inclusion, Day 1

The level of expression of convertase proteins will be determined at plasma level at inclusion, using qRT-PCR, western blot, ELISA, FACs and/or immunofluorescence as methodology and will be correlated with the following immune parameters, determined by immunofluorescence (including but not limited to): CD8, CD4, NK,Tregs, Macrophages.

The analysis will assess the correlation between the expression of various convertases on plasma and immune parameters using Pearson's correlation coefficient for normally distributed variables, or Spearman's correlation coefficient for non-normally distributed variables. The correlation coefficient ranges from -1 to 1: a value closer to 1 indicates a strong positive association, a value closer to -1 indicates a strong negative association, and a value closer to 0 indicates no association.
Inclusion, Day 1

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.
Institut Bergonié

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: Simon PERNOT, Dr, Institut Bergonie

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.
March 27, 2026

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.
January 1, 2028

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.
January 1, 2029

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).
November 22, 2024

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.
November 22, 2024

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.
November 26, 2024

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.
April 20, 2026

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.
April 15, 2026

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.
April 1, 2026

More Information

Terms related to this study

Keywords

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.
  • IB 2024-01
  • 2024-A01797-40 (Other Identifier: ID-CRB)

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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