ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05629442
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ctDNA — OTHER
    initial research biopsy, quality of life assessments and ctDNA collection

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: EVALUATION OF CTDNA
    This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care \- Except for the initial research biopsy, quality of life assessments and ctDNA collection

Primary Outcome Measure

Rate of successful non-operative management [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Theodore Hong, MD
[email protected]
(617) 726-6050
Theodore Hong, MD (PRINCIPAL_INVESTIGATOR)
Mass General Cancer Center Newton-Wellesley HospitalNewtonMassachusetts02462
Theodore Hong, MD
[email protected]
(617) 219-1230
Theodore Hong, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Massachusetts General Hospital· Boston, MAMass General Cancer Center Newton-Wellesley Hospital· Newton, MA

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