Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Stage III Colorectal Cancer Clinical Trial

Official title:

Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02842203
• Other study ID #: STUDY19070371
• Secondary ID: U01CA152753
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage III Colorectal Cancer

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA assessment and relation to clinical outcome	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.	up to 5 years
Secondary	ctDNA versus CEA	ctDNA predictors of outcome will be compared to CEA	up to 5 years