ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer (NCT05629442) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
United States60 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.