Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-31 @ 2:28 AM
Study NCT ID:
NCT02842203
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of ctDNA for Monitoring of Stage III Colorectal Cancer
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Use of ctDNA for Monitoring of Stage III Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).
Detailed Description:
Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover. Characteristic of the malignant process, ctDNA can be assessed in plasma and offers the potential of a sensitive and specific biomarker for prognostic information on disease-free or overall survival, and predictive information on chemotherapy resistance and probability of lack of response to treatment. This study will evaluate ctDNA as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC). We will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (\>10 ml), serial plasma specimens every 3 months for up to 3 years and every 6 months in years 4-5 for ctDNA and concurrent carcinoembryonic antigen (CEA) measurement. Clinical outcome and survival will be tracked. The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival and as a monitor of disease recurrence in comparison with CEA.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| U01CA152753 | NIH | None | https://reporter.nih.gov/quic… | View |