Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma

NCT06705335 | Recruiting DMC

• 2 other identifiers: IB 2024-012024-A01797-40
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer

Keywords

Convertases

Outcome Measures

Primary Outcomes (1)

• Correlation coefficients between level of expression of various convertases on the tumor and immune infiltrate

  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 Outcomes (1)

• Correlation coefficients between level of expression of various convertases determined at plasma level and immune infiltrate

  Inclusion, Day 1

Study Arms (1)

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

Interventions

Blood sample OTHER

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.

CONVERCAP patients

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven):
• Indication for biopsy of metastasis(es) performed as part of standard care for patients who already have a histologically confirmed diagnosis of pancreatic cancer.
• 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.
• Whatever the stage of the disease.
• Whatever the type of treatment proposed (systemic, surgery, radiotherapy, etc.).
• Patient who has never received systemic treatment or advanced radiotherapy.
• WHO 0-1-2.
• Life expectancy \> 3 months.
• Patient affiliated to a social security scheme in compliance with Article 1121-11 of the French Public Health Code.

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreas or metastases tumor sample Blood sample

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Simon PERNOT, Dr

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon PERNOT, Dr

CONTACT

+33556333347; s.pernot@bordeaux.unicancer.fr

Caroline LALET

CONTACT

c.lalet@bordeaux.unicancer.fr

Study Design

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

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: March 27, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

FR (1)