Blood test could revolutionize rectal cancer monitoring
NCT ID NCT05629442
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study looks at whether a blood test that finds tiny bits of tumor DNA (ctDNA) can help doctors monitor rectal cancer more closely than standard scans. Researchers will collect blood and tissue samples from 60 adults with non-spreading rectal cancer before and after standard treatments. The goal is to see if ctDNA can predict if the cancer is completely gone or if it comes back, potentially allowing some patients to avoid surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non metastatic rectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mass General Cancer Center Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy added to standard treatment aims to save the anus in Ultra-Low rectal cancer
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?