Two cohorts of participants will be enrolled: Cohort A (participants appropriate for receiving TNT) and Cohort B (TNT already performed at UC Davis Health or externally). At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting \[WW\] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.
Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.
Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.
Patients ≥18 years of age at time of consent.
Ability to understand and willingness to sign the informed consent form (ICF).
Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements.
You may not be if
Prior treatment for rectal cancer, except for cohort B.
Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.
Patients on hemodialysis.
Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Clareo Health | ctDNA-Informed Management of Early-Stage Rectal Cancer
