Use of ctDNA for Monitoring of Stage III Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02842203
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : February 6, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh

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
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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of ctDNA for Monitoring of Stage III Colorectal Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ctDNA assessment and relation to clinical outcome [ Time Frame: 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 :
  1. ctDNA versus CEA [ Time Frame: up to 5 years ]
    ctDNA predictors of outcome will be compared to CEA

Biospecimen Retention:   Samples With DNA
blood samples; formalin-fixed, paraffin-embedded tumor blocks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present in a UPMC Cancer Center and meet the criteria for this study will be approached by their treating physician about participation.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02842203

Contact: Lynda Dzubinski 412-648-9116
Contact: Robert Schoen, MD 412-864-7086

United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Principal Investigator: Robert Schoen, MD University of Pittsburgh

Responsible Party: Robert Schoen, Professor of Medicine & Epidemiology, University of Pittsburgh Identifier: NCT02842203     History of Changes
Other Study ID Numbers: PRO16020374
U01CA152753 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be made available according to NIH data sharing policies.

Keywords provided by Robert Schoen, University of Pittsburgh:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases