NCT05629442

ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rectal Cancer
• Non Metastatic Rectal Cancer

Interventions

Type	Name	Description
OTHER	ctDNA	initial research biopsy, quality of life assessments and ctDNA collection

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-06-01
• Completion: 2030-06-01
• First posted: 2022-11-29
• Last updated: 2022-11-29

Locations

2 sites across 1 country: United States