Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT05103969
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort of Tumors With POLE/D1 Mutation
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Study Overview
Official Title:
Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined
Detailed Description:
The identification of patients to be included will be done directly from the tumor genotyping platforms.
Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.
The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.
The diagnostic and follow-up data of each patient will be collected prospectively.
Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.
The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.
The diagnostic and follow-up data of each patient will be collected prospectively.
Study Oversight
Has Oversight DMC:
False
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?: