- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296970
An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal of Basal Cell Carcinoma of the Skin With Long Term Follow up to Evaluate Recurrence
April 3, 2019 updated by: Timothy Patton, DO, University of Pittsburgh
Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell carcinoma (BCC) without the need for a follow up surgical procedure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Basal cell carcinoma (BCC) is the most common skin cancer in the world, with approximately 3.5 million cases a year diagnosed in the United States.
BCC are indolent and metastasis is extremely rare, occurring in less than .003% of cases.
However, due to the high prevalence of this tumor, significant health care resources are used in its diagnosis and treatment.
Management of BCC in many instances includes clinical evaluation of the lesion, biopsy or sampling of the lesion to confirm the diagnosis, followed by definitive treatment at a later date through surgical excision or medical therapy.
A clinical diagnosis of BCC can be made with a high degree of confidence based on clinical findings.
The investigators propose that by performing a deep shave removal of the entire lesion with histologically negative margins, based upon clinical diagnosis, complete removal can be achieved without the need for follow up therapy.
Deep shave removal at time of initial evaluation is performed in many instances.
The investigators believe that doing a deep shave removal would substantially reduce the number of second procedures that need to be done, thereby reducing treatment costs and patients' need to return for an additional procedure.
In doing a deep shave removal, clinically diagnosed BCC will be removed entirely with narrow 2-3 mm margins, the tissue specimen will then be sent to the pathologist to confirm that margins are clear.
The investigators will consider treatment of the BCC to be complete at this point and will follow the patients clinically.
Study Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Shadyside Place
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients 18 or older with the clinical diagnosis of BCC
Description
Inclusion Criteria:
- Patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a BCC, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
- Subject is able to give informed consent
- Subject is able to commit to 6 month follow up visit
Exclusion Criteria:
- BCC > 1cm in diameter on any one axis.
- Immunosuppressed patients
- Subjects with neutropenia
- Organ transplant patients
- Subjects with a life expectancy less than year
- Patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral Tacrolimus, any Tumor Necrosis Factor (TNF)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
- Basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
- Subjects unable to provide informed consent
- Subjects unable to commit to 6 month follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of clinical cure rate of deep shave removal in the treatment of BCC
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of deep shave removal BCC with clear margins
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Timothy J Patton, DO, University of Pittsburgh Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ahnlide I, Bjellerup M. Accuracy of clinical skin tumour diagnosis in a dermatological setting. Acta Derm Venereol. 2013 May;93(3):305-8. doi: 10.2340/00015555-1560.
- Ek EW, Giorlando F, Su SY, Dieu T. Clinical diagnosis of skin tumours: how good are we? ANZ J Surg. 2005 Jun;75(6):415-20. doi: 10.1111/j.1445-2197.2005.03394.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
November 12, 2014
First Submitted That Met QC Criteria
November 18, 2014
First Posted (Estimate)
November 21, 2014
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO14020682
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Basal Cell Carcinoma
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | BCC | BCC - Basal Cell Carcinoma | Basal Cell CancerUnited States
-
Christopher ZacharyRecruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
MediWound LtdRecruitingNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
University of MiamiCompletedNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
University Hospital, BordeauxCompletedLocally Advanced Basal Cell Carcinoma | Metastatic Basal Cell CarcinomaFrance
-
Graceway Pharmaceuticals, LLCCompletedSuperficial Basal Cell CarcinomaAustralia, New Zealand
-
Seton Healthcare FamilyUniversity of Texas at Austin; Dell Medical School at The University of Texas...WithdrawnBasal Cell Carcinoma (BCC) | Squamous Cell Carcinoma (SCC)
-
Biofrontera Bioscience GmbHAccovion GmbHCompletedBasal Cell Carcinoma (BCC)Germany
-
Berg, LLCCompletedSuperficial Basal Cell CarcinomaUnited States
-
PeplinCompletedSuperficial Basal Cell CarcinomaAustralia