Official Title
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer
Brief Title
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer
Protocol ID
NCT03749083
Lead Sponsor
Massachusetts General Hospital
Brief Summary
In this research study, the investigators are looking to see if the circulating tumor DNA
(genetic material), also known as ctDNA, in the blood will help them predict whether the
participant's cancer will come back.
Detailed Description
In this research study, the investigator are performing blood draws to see if the
presence or absence of circulating tumor DNA (ctDNA), the genetic material in the
participant's cancer's cells, will help the investigators predict whether the
participant's cancer will come back or not.
Study Period
-
Enrollment Count
0 participants
Eligibility Criteria
Inclusion Criteria:
- Participants must have achieved a clinical complete response (cCR) within 3 months
of last therapy - defined as absence of residual ulceration, mass or mucosal
irregularity at endoscopic assessment - following neoadjuvant therapy with
chemoradiation or chemotherapy followed by radiation for stage I, II, or III
non-metastatic rectal cancer. (Whitening of the mucosa with presence of
telangiectasia will be accepted as cCR.)
- Participants must have original tumor tissue (formalin-fixed, paraffin-embedded
specimens) available for analysis
- Participants must be 18 years of age or older.
- Participants must be able to understand and willing to sign a written informed
consent document.
- Participants must have received long course chemoradiation to 40-54 Gy.
- Participants must have received at least 4 cycles of FOLFOX
- Participant must be no more than 3 months past the conclusion of initial
chemoradiation of rectal cancer (i.e., end of chemoradiation).
Exclusion Criteria:
- Participants may 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.
Filters
Gastrointestinal Malignancies
WITHDRAWN
ADULT
OLDER_ADULT