Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 9:38 PM
Study NCT ID:
NCT06703632
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Sponsor:
ADVANCED MARKER DISCOVERY S.L.
Organization:
Study Overview
Official Title:
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Status:
RECRUITING
Status Verified Date:
2024-11
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:
MS-Prevecol
Brief Summary:
The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:
* Values of efficacy, efficiency, impact and safety of PreveCol.
* Values of preferences of participants for screening methods.
* Values of PREMs into screening programme.
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
* Values of efficacy, efficiency, impact and safety of PreveCol.
* Values of preferences of participants for screening methods.
* Values of PREMs into screening programme.
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-NDMH-5101_240046 | OTHER_GRANT | EIT-Health | View |