Blood test may decide who needs surgery for rectal cancer
NCT ID NCT07209215
First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether a highly sensitive blood test (ctDNA) can help manage treatment for 200 people with early-stage rectal cancer. After standard chemotherapy and radiation, some patients will have their treatment guided by the blood test results instead of immediate surgery. The study aims to see if this approach can achieve similar cancer control while possibly avoiding unnecessary surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Signatera Genome ultra-sensitive ctDNA blood test
- What this could lead to
- If successful, this could show that a blood test helps doctors decide who needs surgery and who can safely avoid it after initial treatment.
- What could go wrong
- This is an early-phase study with only 200 participants. The blood test may not be accurate enough to guide decisions, and results may not apply to all patients.
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.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 200 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
-
Dec 2028
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.
- 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: * Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay. * Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation. * Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation. * Patients ≥18 years of age at time of consent. * Ability to understand and willingness to sign the informed consent form (ICF). * Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements. Exclusion Criteria: * Prior treatment for rectal cancer, except for cohort B. * Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment. * Patients on hemodialysis. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Early-stage 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 study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. 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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Contact Email: •••••@•••••
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
- New injectable drug tested against Hard-to-Treat solid tumors
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Could a nasal tube replace a temporary ileostomy after rectal cancer surgery?
- Can immunotherapy plus chemo melt colorectal tumors before surgery?
- Blood test aims to catch Cancer's return earlier