ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ctDNA
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
C2i Genomics
Collaborator
Source ClinicalTrials.gov