Status:
WITHDRAWN
Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a single-arm observational study to determine the feasibility of assessing tumor response utilizing Circulating tumor DNA (ctDNA) in patients of with locally advanced rectal cancer (LARC) unde...
Detailed Description
In this observational study, patients with LARC who are selected for the standard-of-care TNT will be enrolled. After obtaining informed consent, a venous blood sample and the archival tissue block fr...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically documented rectal cancer eligible for total neoadjuvant therapy (TNT).
- Male or female subjects ≥18 years old.
- Rectal tumor biopsy is available for SignateraTM assay development for ctDNA measurement.
- Patients must be able to understand the informed consent form and provide written consent.
Exclusion
- Patients without available rectal biopsy tissue for SignateraTM assay development.
- Patients with rectal cancer not eligible to receive standard-of-care TNT for any reason.
- Patients with undetectable ctDNA level in the baseline blood sample.
- Patients without trackable mutation in the rectal tumor.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04670588
Start Date
March 31 2021
End Date
June 1 2022
Last Update
July 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226