ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

NCT05629442 | Not Yet Recruiting

• 1 other identifier: 22-244
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rectal Cancer; Non Metastatic Rectal Cancer

Keywords

Rectal Cancer; Non Metastatic Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of successful non-operative management

  1 year

• Rate of successful pathologic complete response

  1 year

Secondary Outcomes (10)

• Rate of local recurrence

  5 years

• EORTC-QLQ-CR 29 questionnaire

  Up to 30 months

• FACT-C questionnaire

  Up to 30 months

• IADL Scale

  Up to 30 months

• Brief Pain Inventory (BPI) questionnaire

  Up to 30 months

Study Arms (1)

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

Other: ctDNA

Interventions

ctDNA OTHER

initial research biopsy, quality of life assessments and ctDNA collection

EVALUATION OF CTDNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.

You may qualify if:

• Participants with T3, T4, or node-positive non-metastatic rectal cancer.
• Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
• Participants must be 18 years of age or older.
• ECOG 0-2.
• Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
• Participants must be eligible for long course chemoradiation to 40-54 Gy.
• Participants must be able to understand and willing to sign a written informed consent document.

You may not qualify if:

• Participants must not have any other organ cancer evident at the time of enrollment.
• Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
• Participants must not be actively or planning to be pregnant or breastfeeding

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• C2i Genomics: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Mass General Cancer Center Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

biospecimen submission should include both tissue and blood samples:

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Theodore S. Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodore S. Hong, MD

CONTACT

(617) 726-6050; TSHONG1@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: November 29, 2022
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)