Official Title
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
Brief Title
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
Protocol ID
NCT05629442
Lead Sponsor
Massachusetts General Hospital
Brief 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.
Detailed Description
The research study procedures include screening for eligibility and the collection of
data and biospecimens. Non-operative management is offered as part of routine clinical
care.
It is expected that up to 60 participants will be enrolled, with the goal that 55
participants will take part in this research study .
Participants enrolled on the study will remain on study for up to 60 months.
Enrollment Count
60 participants
Eligibility Criteria
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
Filters
Rectal Cancer
Non Metastatic Rectal Cancer
NOT_YET_RECRUITING
ADULT
OLDER_ADULT