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Trial record 6 of 373 for:    colorectal | Recruiting Studies | United States

Use of ctDNA for Monitoring of Stage III Colorectal Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Robert Schoen, University of Pittsburgh
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02842203
First received: July 20, 2016
Last updated: January 15, 2017
Last verified: January 2017
  Purpose
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
Stage III Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of ctDNA for Monitoring of Stage III Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Robert Schoen, University of Pittsburgh:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 150
Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02842203

Contacts
Contact: Lynda Dzubinski 412-648-9116 lyd1@pitt.edu
Contact: Robert Schoen, MD 412-864-7086 rschoen@pitt.edu

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

Responsible Party: Robert Schoen, Professor of Medicine & Epidemiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02842203     History of Changes
Other Study ID Numbers: PRO16020374
U01CA152753 ( U.S. NIH Grant/Contract )
Study First Received: July 20, 2016
Last Updated: January 15, 2017
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 23, 2017