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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05081024
Status
Recruiting
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Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and/or tissue samples
  • Electronic Health Record Review — OTHER
    Medical records are reviewed

Study Details

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.

Key Dates

Start date
Sep 3, 2021
Status verified
Sep 2025
Primary completion
Sep 3, 2026
Completion
Sep 3, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Observational (biospecimen collection, medical record review)
    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.

Primary Outcome Measure

Complete clinical response (cCR) [ Time Frame: From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Adel Kardosh, M.D.,Ph.D.
[email protected]
503-494-5207
Adel Kardosh, M.D.,Ph.D. (PRINCIPAL_INVESTIGATOR)
Fred HutchSeattleWashington98109
Stacey Cohen, MD
[email protected]
206-606-6658

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By research site
OHSU Knight Cancer Institute· Portland, ORFred Hutch· Seattle, WA

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