Back to resultsPatient-Derived Organoids for Rectal Cancer
Primary Purpose
Rectum Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional other trial for Rectum Cancer
Eligibility Criteria
Inclusion
- Age ≥18 years old.
- Able to provide informed consent.
- Undergoing proctoscopy.
Exclusion
1. Patient not planned to receive neoadjuvant radiotherapy
Sites / Locations
- Duke Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Organoid
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Biopsies That Form Spherical Organoids
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04371198
Brief Title
Patient-Derived Organoids for Rectal Cancer
Official Title
Feasibility of Establishing Patient-Derived Organoids for Rectal Cancer: A Biospecimen Collection Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Organoid
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Biopsy
Intervention Description
Tissue biopsy
Primary Outcome Measure Information:
Title
Number of Participants With Biopsies That Form Spherical Organoids
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Age ≥18 years old.
Able to provide informed consent.
Undergoing proctoscopy.
Exclusion
1. Patient not planned to receive neoadjuvant radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Czito, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and organoids may be shared with other researchers
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Researchers should request data and/or organoid lines from the principal investigator
Learn more about this trial
Patient-Derived Organoids for Rectal Cancer
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