An observational study in Rectal Cancer and Non Metastatic Rectal Cancer, sponsored by Massachusetts General Hospital. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Massachusetts General Hospital · Observational
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 60 is below the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Exclusion Criteria:
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
initial research biopsy, quality of life assessments and ctDNA collection
Rate of successful non-operative management
Time frame: 1 year
Rate of successful pathologic complete response
Time frame: 1 year
Rate of local recurrence
Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay.
Time frame: 5 years
EORTC-QLQ-CR 29 questionnaire
European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer. Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning.
Time frame: Up to 30 months
FACT-C questionnaire
Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life.
Time frame: Up to 30 months
IADL Scale
Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function). IADLs are things you do every day to independently take care of yourself and your home.
Time frame: Up to 30 months
Brief Pain Inventory (BPI) questionnaire
Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer. BPI scale total score: * worst pain score: 1-4 = mild pain * worst pain score: 5-6 = moderate pain * worst pain score: 7-10 = severe pain
Time frame: Up to 30 months
Bowel function assessment with LARS score
Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer. LARS total score: * 0-20 = no dysfunction * 21-29 = minor dysfunction * 30-42 = major dysfunction
Time frame: Up to 30 months
Bowel function assessment with FISI score
Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life. Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life.
Time frame: Up to 30 months
Bowel function assessment with FIQOL score
Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life.
Time frame: Up to 30 months
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer.
Time frame: Up to 30 months
Overall Survival (OS)
Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.
Time frame: Up to 30 months
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital