Back to search results

Observational Study of ctDNA in Rectal Cancer

This observational study is looking at how circulating tumor DNA (ctDNA), which is genetic material from cancer cells found in your blood, might help doctors monitor non-metastatic (cancer that hasn't spread) rectal cancer. Researchers want to see if ctDNA can help detect if the cancer comes back sooner than standard scans. You might be able to join if you have T3, T4, or node-positive rectal cancer and are at least 18 years old. The study will measure how many patients successfully avoid surgery (non-operative management) and how many achieve a complete response to treatment, both at one year. The study is currently recruiting up to 60 participants.

Study design
This is an observational study, meaning it collects information without giving new treatments. It plans to enroll up to 60 participants.
What's involved
You would undergo screening for eligibility and provide blood and tissue samples. You will remain in the study for up to 60 months.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 1 year, and participants will be followed for up to 60 months.

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

NCT05629442

ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Not Yet Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~60 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:ctDNA

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of successful non-operative management
Measured over 1 year
+1 more outcome measured

Conditions

Rectal Cancer
Non Metastatic Rectal Cancer

Explore related trials

Rectal Carcinoma

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Hannah J. Roberts, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Hannah J. Roberts, MD
[email protected]
617-726-5184
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of successful non-operative management1 year
  • Rate of successful pathologic complete response1 year