Status:
WITHDRAWN
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Colorectal Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referr...
Detailed Description
Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study. One 6 mL tube of blood will ...
Eligibility Criteria
Inclusion
- Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
- Plan is for participant to undergo standard TNT with induction chemoradiation
- Age ≥ 18 years of age
Exclusion
- Stage I, recurrent, or metastatic rectal cancer
- Received prior therapy for this rectal cancer
- No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development
Key Trial Info
Start Date :
December 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05356585
Start Date
December 30 2023
End Date
June 30 2024
Last Update
April 12 2024
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195