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

Last updated: February 20, 2025
Sponsor: OHSU Knight Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Adenocarcinoma

Rectal Cancer

Treatment

Electronic Health Record Review

Biopsy

Biospecimen Collection

Clinical Study ID

NCT05081024
STUDY00022247
NCI-2021-08733
STUDY00022247
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must provide written informed consent before any study-specificprocedures or interventions are performed

  • Participants aged >= 18 years

  • Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:

  • T3N0M0 - T4bN2M0

Exclusion

Exclusion Criteria:

  • Has radiologic evidence of distant metastases at the time of screening/enrollment

  • Has received prior treatment for their rectal adenocarcinoma

  • Requires or has received blood transfusion within 1 month of study enrollment

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
September 03, 2021
Estimated Completion Date:
September 03, 2025

Study Description

PRIMARY OBJECTIVE:

I. To estimate the percentage of participants that achieve complete clinical response.

SECONDARY OBJECTIVES:

I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT).

II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS).

EXPLORATORY OBJECTIVES:

I. To characterize ctDNA clearance or non-clearance patterns during TNT. II. To correlate ctDNA levels with a participant's pathological features. III. To preliminary assess the prognostic performance of ctDNA levels in relation to participant's clinical outcome.

OUTLINE:

Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.

Connect with a study center

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

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