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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01097 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2008-0266 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
PRIMARY OBJECTIVES:
I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.
II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.
SECONDARY OBJECTIVE:
I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.
OUTLINE:
Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (SLN localization and biopsy) | Experimental | Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymph Node Mapping | Procedure | Undergo lymph node mapping |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel Lymph Node Positivity | Number of patients who had a positive sentinel lymph node | One year after the surgical procedure under study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bita M Esmaeli | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Patients with sebaceous carcinoma of the eyelid treated at MDA from 2009-2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Sebaceous Carcinoma Who Opted to Receive SLN Biopsy | There was only one arm to the study as this was a feasibility study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid | Patients with sebaceous carcinoma who opted to receive SLN biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sentinel Lymph Node Positivity | Number of patients who had a positive sentinel lymph node | Posted | Count of Participants | Participants | One year after the surgical procedure under study. |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid | Patients with sebaceous carcinoma who opted to receive SLN biopsy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Hull | M D Anderson Cancer Center | 713-563-4598 | sehull@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2024 | Jun 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Sentinel Lymph Node Biopsy | Procedure | Undergo SLN biopsy |
|
|
| Technetium Tc-99m Sulfur Colloid | Drug | Given ID |
|
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |