Trial Outcomes & Findings for Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid (NCT NCT00832429)
NCT ID: NCT00832429
Last Updated: 2025-07-04
Results Overview
Number of patients who had a positive sentinel lymph node
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
One year after the surgical procedure under study.
Results posted on
2025-07-04
Participant Flow
Patients with sebaceous carcinoma of the eyelid treated at MDA from 2009-2021
Participant milestones
| Measure |
Patients With Sebaceous Carcinoma Who Opted to Receive SLN Biopsy
There was only one arm to the study as this was a feasibility study
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lymph Node Mapping in Finding Metastatic Disease in Patients With Sebaceous Gland Cancer of the Eyelid
Baseline characteristics by cohort
| Measure |
Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
n=20 Participants
Patients with sebaceous carcinoma who opted to receive SLN biopsy
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year after the surgical procedure under study.Number of patients who had a positive sentinel lymph node
Outcome measures
| Measure |
Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
n=20 Participants
Patients with sebaceous carcinoma who opted to receive SLN biopsy
|
|---|---|
|
Sentinel Lymph Node Positivity
|
2 Participants
|
Adverse Events
Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place