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

NCT05081024 | Recruiting

• 2 other identifiers: STUDY00022247NCI-2021-08733
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Complete clinical response (cCR)

  cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented.

  From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.

Secondary Outcomes (7)

• Positive circulating tumor deoxyribonucleic acid (ctDNA)

  From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years.

• Positive ctDNA after completing TNT

  From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years

• Rate of transabdominal surgery

  Up to 3 years following completion of TNT

• Rate of pathological complete response (pCR)

  From start of treatment until completion of surgery, up to 3 years.

• Rate of watch and wait strategy

  Up to 3 years following completion of TNT

Other Outcomes (4)

• ctDNA status

  From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years

• Positive ctDNA by clinical characteristics

  From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT

• Sensitivity

  From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT

Study Arms (1)

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Observational (biospecimen collection, medical record review)

Biospecimen Collection PROCEDURE

Undergo collection of blood and/or tissue samples

Also known as: Biological Sample Collection

Observational (biospecimen collection, medical record review)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (biospecimen collection, medical record review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II-III rectal adenocarcinoma at Oregon Health \& Science University (OHSU), its affiliated community oncology (CHO) site, or collaborating research site

You may qualify if:

• Participant must provide written informed consent before any study-specific procedures or interventions are performed
• Participants aged \>= 18 years
• Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
• T3N0M0 - T4bN2M0

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Natera, Inc.: collaborator

Study Sites (2)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

Fred Hutch

Seattle, Washington, 98109, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Adel Kardosh, M.D.,Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 18, 2021
• Study Start: September 3, 2021
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (2)