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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Washington
Fred Hutch
RECRUITING
Seattle
Time Frame
Start Date: 2021-09-03
Estimated Completion Date: 2026-09-03
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Natera, Inc.
Leads: OHSU Knight Cancer Institute

This content was sourced from clinicaltrials.gov