ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
NCT ID: NCT05629442
Last Updated: 2022-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2023-01-31
2030-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EVALUATION OF CTDNA
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care
\- Except for the initial research biopsy, quality of life assessments and ctDNA collection
ctDNA
initial research biopsy, quality of life assessments and ctDNA collection
Interventions
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ctDNA
initial research biopsy, quality of life assessments and ctDNA collection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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C2i Genomics
INDUSTRY
Spier Family Foundation
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
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Theodore Sunki Hong
Principal Investigator
Principal Investigators
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Theodore S. Hong, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Mass General Cancer Center Newton-Wellesley Hospital
Newton, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-244
Identifier Type: -
Identifier Source: org_study_id
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