Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02842203

Enrollment

137

Registered

2016-07-22

Start date

2016-09-30

Completion date

2026-09-30

Last updated

2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Colorectal Cancer

Keywords

colorectal cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
ctDNA versus CEA	up to 5 years	ctDNA predictors of outcome will be compared to CEA

Countries

United States

Outcome results