Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766502
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2021-02-09
Brief Title:
Bonds Between Circulating Tumoral ADN ctDNA and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC
Sponsor:
Institut de Cancérologie de Lorraine
Organization:
Institut de Cancérologie de Lorraine
Study Overview
Official Title:
Study Evaluating the Bonds Between Circulating Tumoral ADN ctDNA and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC
Status:
RECRUITING
Status Verified Date:
2023-07
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:
PIPADN
Brief Summary:
PIPADN is a pilot monocentric study with a total duration of 42 months The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis
The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey
Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart Two blood samples will be taken during the first 3 PIPAC sessions one the day before each procedure and a second one 24 hours afterwards
The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation about 3 weeks after PIPAC sessions
The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey
Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart Two blood samples will be taken during the first 3 PIPAC sessions one the day before each procedure and a second one 24 hours afterwards
The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation about 3 weeks after PIPAC sessions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None