Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01624 | Registry Identifier | NCI Trial Identification | |
| JT 2143 | Other Identifier | JeffTrial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.
PRIMARY OBJECTIVES:
I. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).
SECONDARY OBJECTIVES:
I. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (surgical excision) | Experimental | Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Conventional Surgery | Procedure | Undergo surgical excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate for 1 mm margins | The success rate for 1 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion. | Up to 3 years |
| Success rate for 2 mm margins | The success rate for 2 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate after 3 years | Up to 3 years |
Not provided
Inclusion Criteria:
Location
Well-defined borders
Primary BCC
Patient is not immunosuppressed
There has not been prior radiotherapy to the site
Nodular subtype
No perineural involvement-(no neurological deficits grossly) -
Exclusion Criteria:
Location
Poorly defined borders
Recurrent BCC
Patient is immunosuppressed
There has been prior radiotherapy to the site -
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Lee, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson Univeristy | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D018295 |
| Neoplasms, Basal Cell |