Trial Outcomes & Findings for Patient-Derived Organoids for Rectal Cancer (NCT NCT04371198)
NCT ID: NCT04371198
Last Updated: 2023-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2023-08-28
Participant Flow
Participant milestones
| Measure |
Organoid
Biopsy: Tissue biopsy
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Organoid
Biopsy: Tissue biopsy
|
|---|---|
|
Overall Study
inadequate sample
|
4
|
Baseline Characteristics
Patient-Derived Organoids for Rectal Cancer
Baseline characteristics by cohort
| Measure |
Organoid
n=20 Participants
Biopsy: Tissue biopsy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants with sufficient sample collected.
Outcome measures
| Measure |
Organoid
n=16 Participants
Biopsy: Tissue biopsy
|
|---|---|
|
Number of Participants With Biopsies That Form Spherical Organoids
|
14 Participants
|
Adverse Events
Organoid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joan Cahill BNS OCN CCRP
Duke University Health System
Phone: (919) 668-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place