RECRUITING

Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.

Official Title

Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer

Quick Facts

Study Start:2021-09-03
Study Completion:2024-09-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05081024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must provide written informed consent before any study-specific procedures or interventions are performed
  2. * Participants aged \>= 18 years
  3. * Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
  4. * T3N0M0 - T4bN2M0
  1. * Has radiologic evidence of distant metastases at the time of screening/enrollment
  2. * Has received prior treatment for their rectal adenocarcinoma
  3. * Requires or has received blood transfusion within 1 month of study enrollment

Contacts and Locations

Principal Investigator

Adel Kardosh, M.D.,Ph.D.
PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

  • Adel Kardosh, M.D.,Ph.D., PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-03
Study Completion Date2024-09-03

Study Record Updates

Study Start Date2021-09-03
Study Completion Date2024-09-03

Terms related to this study

Additional Relevant MeSH Terms

  • Rectal Adenocarcinoma
  • Stage II Rectal Cancer AJCC v8
  • Stage IIA Rectal Cancer AJCC v8
  • Stage IIB Rectal Cancer AJCC v8
  • Stage IIC Rectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8