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2025-01
2028-01
2029-01
50
NCT06705335
Institut Bergonié
Institut Bergonié
OBSERVATIONAL
Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma
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.
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blood sample was not taken or is not available, or * the patient refuses to continue the study, or * the patient has withdrawn consent, or * any other reason preventing inclusion of the patient.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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-11-22 | N/A | 2024-11-22 |
2024-11-22 | N/A | 2024-11-26 |
2024-11-26 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 adeno | OTHER: Blood sample
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Correlation coefficients between level of expression of various convertases determined at plasma level and immune infiltrate | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Simon PERNOT, Dr Phone Number: +33556333347 Email: s.pernot@bordeaux.unicancer.fr |
Study Contact Backup Name: Caroline LALET Phone Number: Email: c.lalet@bordeaux.unicancer.fr |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
