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Trial Title:
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
NCT ID:
NCT05629442
Condition:
Rectal Cancer
Non Metastatic Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Rectal Cancer
Non Metastatic Rectal Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
ctDNA
Description:
initial research biopsy, quality of life assessments and ctDNA collection
Arm group label:
EVALUATION OF CTDNA
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.
Detailed 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.
Criteria for eligibility:
Study pop:
This prospective observational, non-therapeutic study will enroll patients with T3, T4,
or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Sampling method:
Non-Probability Sample
Criteria:
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.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Contact:
Last name:
Theodore Hong, MD
Phone:
617-726-6050
Email:
TSHONG1@mgh.harvard.edu
Investigator:
Last name:
Theodore Hong, MD
Email:
Principal Investigator
Facility:
Name:
Mass General Cancer Center Newton-Wellesley Hospital
Address:
City:
Newton
Zip:
02462
Country:
United States
Contact:
Last name:
Theodore Hong, MD
Phone:
617-219-1230
Email:
TSHONG1@mgh.harvard.edu
Investigator:
Last name:
Theodore Hong, MD
Email:
Sub-Investigator
Start date:
January 2023
Completion date:
June 2030
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
C2i Genomics
Agency class:
Industry
Collaborator:
Agency:
Spier Family Foundation
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05629442
