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ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer

Clinical Trial Summary

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

Clinical Trial Description

The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care. It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study . Participants enrolled on the study will remain on study for up to 60 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05629442
Study type Observational
Source Massachusetts General Hospital
Contact Theodore S. Hong, MD
Phone (617) 726-6050
Email TSHONG1@mgh.harvard.edu
Status Not yet recruiting
Phase
Start date January 2023
Completion date June 2030
View Details
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