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

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Stage IIC Rectal Cancer AJCC v8; Stage IIA Rectal Cancer AJCC v8; Rectal Adenocarcinoma; Stage II Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05081024

NCI-2021-08733 (Registry Identifier)

STUDY00022247 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

50 participants in 1 patient group

Observational (biospecimen collection, medical record review)

Description:

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.

Treatment:

Procedure: Biopsy

Other: Electronic Health Record Review

Procedure: Biospecimen Collection