Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT07230795
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-17
First Post:
2025-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-informed Colorectal Cancer (CRC) Screening Navigation vs. Standard of Care Among Screening-naive Penn Medicine Patients 45-49 Years Old to Increase CRC Screening Uptake
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
AI-informed Colorectal Cancer (CRC) Screening Navigation vs. Standard of Care Among Screening-naive Penn Medicine Patients 45-49 Years Old to Increase CRC Screening Uptake
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
This project aims to use machine learning algorithms (MLA) to identify and risk-stratify individuals between the ages of 45-49 who are more likely to have colorectal pathology and merit prioritized CRC screening and patient navigation. Patients deemed to be at higher risk for CRC by MLA will be randomized to an intervention group to receive risk-informed patient navigation and a usual care control group. The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. For the usual care control group, patients may still receive patient navigation for colonoscopy assistance. A referral to a nurse navigator can be initiated by a healthcare staff member in the following ways: 1) procedure scheduling staff will provide navigator's contact number if the patient expresses difficulty with obtaining a ride home 2) endoscopy staff and physicians can message navigator electronically 3) PCPs can place a navigation order in the EHR for patients deemed to need additional support such as with prep, education, transportation 4) providers will directly contact the director of the navigation system (Dr. Carmen Guerra) for referral.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 858875 | OTHER | Penn IRB | View |