NCT05629442Withdrawn
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Observational
- Enrollment
- 0 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 1 Oct 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05629442
What you commit to
- Study type: Observational
- Participants enrolled: 0
- From 1 Oct 2026 to the primary completion date, Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
Other illness
- Participants must not have any other organ cancer evident at the time of enrollment.
Other
- Participants must not be actively or planning to be pregnant or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.