Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06705335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
Convertases and Pancreatic Cancer. New Therapeutic and Prognostic Approach: Cohort of Patients Treated for Pancreatic Adenocarcinoma (CONVERCAP)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONVERCAP
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.
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* the patient has withdrawn consent, or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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A01797-40 | OTHER | ID-CRB | View |