Rectal CancerNCT05629442
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
An observational study of Rectal Cancer and Non Metastatic Rectal Cancer, run by Massachusetts General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Non Metastatic Rectal Cancer
- What is being tested?
- ctDNA
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Jun 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official 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
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.
Read the 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
- Being tested
- ctDNA
- Keywords
- Rectal Cancer, Non Metastatic Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNAOther
initial research biopsy, quality of life assessments and ctDNA collection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful non-operative management
Measured: 1 year
Rate of successful pathologic complete response
Measured: 1 year
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Oct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- C2i Genomics
- Responsible party
- Principal investigator, Hannah Roberts, Massachusetts General Hospital
- Investigators
- Hannah J. Roberts, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629442
- Sponsor's protocol ID
- 22-244
- Status last verified
- Nov 2026
- First submitted
- 14 Sep 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05629442
- Acronym / sponsor ID
- 22-244
- Conditions
- Rectal Cancer, Non Metastatic Rectal Cancer
- Keywords
- Rectal Cancer, Non Metastatic Rectal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- C2i Genomics
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVALUATION OF CTDNA | – | Other: ctDNAThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNAinitial research biopsy, quality of life assessments and ctDNA collection | Other | EVALUATION OF CTDNA |
Primary outcome
Rate of successful non-operative management
Time frame: 1 year
Rate of successful pathologic complete response
Time frame: 1 year
10 secondary outcomes
Rate of local recurrence
Time frame: 5 years
EORTC-QLQ-CR 29 questionnaire
Time frame: Up to 30 months
FACT-C questionnaire
Time frame: Up to 30 months
IADL Scale
Time frame: Up to 30 months
Brief Pain Inventory (BPI) questionnaire
Time frame: Up to 30 months
Bowel function assessment with LARS score
Time frame: Up to 30 months
Bowel function assessment with FISI score
Time frame: Up to 30 months
Bowel function assessment with FIQOL score
Time frame: Up to 30 months
Disease-free survival (DFS)
Time frame: Up to 30 months
Overall Survival (OS)
Time frame: Up to 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah J. Roberts, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Non Metastatic Rectal Cancer, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful non-operative management (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.