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ctDNA-Informed Management of Early-Stage Rectal Cancer Study

This study is looking at a new way to manage early-stage rectal cancer using a blood test called Signatera Genome ultra-sensitive ctDNA. After you've had total neoadjuvant therapy (TNT), which is chemotherapy and radiation before surgery, this blood test helps doctors decide the best next steps for your treatment. The study wants to see if this approach leads to a complete response to treatment (pathologic complete response or pathCR) and how long people live without the cancer returning (disease-free survival or DFS). You might be able to join if you have rectal adenocarcinoma, are at least 18 years old, and have tumor tissue available for testing. The study is currently unclear about its recruitment status.

Study design
This is a phase 2 study planning to enroll 200 participants. It will compare two groups: one where treatment is guided by the ctDNA blood test, and another where standard surgery is performed after TNT.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in the ctDNA informed management arm will be monitored for up to 2 years after TNT for pathCR and DFS. Participants will be monitored for ctDNA positivity for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07209215

ctDNA-Informed Management of Early-Stage Rectal Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Davis
~200 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
Measured over Up to 2 years after TNT
+2 more outcomes measured

Conditions

Rectal Adenocarcinoma
Rectal Cancer
Early-stage Rectal Cancer
Locally Advanced Rectal Adenocarcinoma

Explore related trials

Rectal Adenocarcinoma

NCT07209215

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California Davis Comprehensive Cancer Center

    Sacramento, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ankit Sarin, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Office of Clinical Research
[email protected]
916-382-6970
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)Up to 2 years after TNT

    Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)

  • Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)Up to 2 years after TNT

    Percent of participants with local regrowth within 2 years of TNT

  • Disease-free survival (DFS) rate (ctDNA Informed Management Arm)Up to 2 years after TNT

    Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.