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
Massachusetts General Hospital
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Ex…
Interventions
- OtherctDNA
initial research biopsy, quality of life assessments and ctDNA collection
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Mass General Cancer Center Newton-Wellesley HospitalNewton, Massachusetts