Status:
WITHDRAWN
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
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Clinical Genomics
Conditions:
Gastrointestinal Malignancies
Eligibility:
All Genders
18+ years
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 ...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03749083
Start Date
December 31 2019
End Date
October 31 2024
Last Update
July 8 2019
Active Locations (4)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02214
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215
4
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02459