Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Sponsor

University of Pittsburgh (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02842203

Collaborator

National Cancer Institute (NCI) (NIH)

137

Enrollment

Location

108

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stage III Colorectal Cancer

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 Design

Study Type:

Observational

Actual Enrollment :

137 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Outcome Measures

Primary Outcome Measures

ctDNA assessment and relation to clinical outcome [up to 5 years]
The relationship between ctDNA and survival (both progression-free and overall) will be evaluated. Both the total load of ctDNA and the specific mutation(s) identified will be evaluated.

Secondary Outcome Measures

ctDNA versus CEA [up to 5 years]
ctDNA predictors of outcome will be compared to CEA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women with CRC Stage III A, B, or C
Age ≥18 years
Willingness to provide blood samples for research purposes
Ability to understand written informed consent document, and written informed consent provided

Exclusion Criteria:

Blood sampling would compromise patients overall health such as presence of severe anemia
Unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

University of Pittsburgh
National Cancer Institute (NCI)

Investigators

Principal Investigator: Robert Schoen, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Schoen, Professor of Medicine & Epidemiology, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT02842203

Other Study ID Numbers:

STUDY19070371
U01CA152753

First Posted:

Jul 22, 2016

Last Update Posted:

Nov 3, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Robert Schoen, Professor of Medicine & Epidemiology, University of Pittsburgh

colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Nov 3, 2021