Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01903395
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Organization:
Study Overview
Official Title:
Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
Status:
COMPLETED
Status Verified Date:
2016-10
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:
FAMKOL
Brief Summary:
BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. Nevertheless, participation in the German national screening program stagnates at 2-3 percent per year even in this high-risk population.
AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.
METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.
AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.
METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: