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NCT Number: NCT05629442

ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Non Metastatic Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

ctDNA

Other

initial research biopsy, quality of life assessments and ctDNA collection

Primary outcomes

  1. Rate of successful non-operative management

    Time frame: 1 year

  2. Rate of successful pathologic complete response

    Time frame: 1 year

Secondary outcomes

  1. Rate of local recurrence

    Time frame: 5 years

    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.

  2. EORTC-QLQ-CR 29 questionnaire

    Time frame: Up to 30 months

    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.

  3. FACT-C questionnaire

    Time frame: Up to 30 months

    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.

  4. IADL Scale

    Time frame: Up to 30 months

    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.

  5. Brief Pain Inventory (BPI) questionnaire

    Time frame: Up to 30 months

    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

  6. Bowel function assessment with LARS score

    Time frame: Up to 30 months

    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

  7. Bowel function assessment with FISI score

    Time frame: Up to 30 months

    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.

  8. Bowel function assessment with FIQOL score

    Time frame: Up to 30 months

    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.

  9. Disease-free survival (DFS)

    Time frame: Up to 30 months

    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.

  10. Overall Survival (OS)

    Time frame: Up to 30 months

    Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah J. Roberts, MD

CONTACT

[email protected]

617-726-5184

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • C2i Genomics

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Nov 29, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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