Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

Last updated: April 11, 2024
Sponsor: Case Comprehensive Cancer Center
Overall Status: Trial Not Available

Phase

N/A

Condition

Colon Cancer

Digestive System Neoplasms

Rectal Disorders

Treatment

SignateraTM assay

Clinical Study ID

NCT05356585
CASE9221
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma withMRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or IIIdisease
  • Plan is for participant to undergo standard TNT with induction chemoradiation
  • Age ≥ 18 years of age

Exclusion

Exclusion Criteria:

  • Stage I, recurrent, or metastatic rectal cancer
  • Received prior therapy for this rectal cancer
  • No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue frombiopsies available to send for SignateraTM assay development

Study Design

Treatment Group(s): 1
Primary Treatment: SignateraTM assay
Phase:
Study Start date:
December 30, 2023
Estimated Completion Date:
June 30, 2024

Study Description

Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.

One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).

The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .

The secondary objectives of the study include:

  1. Estimating the change in ctDNA after chemoradiation and chemotherapy

  2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA

  3. Describe the recurrence rate in participants with and without ctDNA after TNT

  4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.

Connect with a study center

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

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