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| ID | Type | Description | Link |
|---|---|---|---|
| PRMC_CO08303 | Other Identifier | University of Wisconsin Carbone Cancer Center |
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slow enrollment, lack of funding
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| Name | Class |
|---|---|
| Skin Cancer Foundation | UNKNOWN |
| Dermatology Foundation | OTHER |
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This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers. One cycle of ED&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ED&C times 3 cycles | Active Comparator |
| |
| ED & C times 1 cycle | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrodessication & Curettage | Procedure | Electrodessication & Curettage 1 or 3 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | Clinical evidence of BCC recurrence post treatment | base line, every 3 months until 12 month completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Berg, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison, Department of Dermatology | Madison | Wisconsin | 53715 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ED&C Times 3 Cycles | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
| FG001 | ED & C Times 1 Cycle | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | ED&C Times 3 Cycles | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
| BG001 | ED & C Times 1 Cycle | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | Clinical evidence of BCC recurrence post treatment | Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived. | Posted | Number | participants | base line, every 3 months until 12 month completion |
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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 | ED&C Times 3 Cycles | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment | mild to moderate itching at the site of treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Administrator | University of Wisconsin-Madison | 608-287-2640 | dbock@dermatology.wisc.edu |
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| ID | Term |
|---|---|
| D003475 | Curettage |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| study termination |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles |
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|
| 0 |
| 41 |
| 7 |
| 41 |
| EG001 | ED & C Times 1 Cycle | Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles | 0 | 44 | 7 | 44 |
|
| infection | Skin and subcutaneous tissue disorders | Systematic Assessment | infection at site of treatment |
|
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