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| Name | Class |
|---|---|
| Eminence Clinical Research, Inc. | INDUSTRY |
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This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Brachytherapy | Procedure/Surgery: Electronic Brachytherapy: Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System. High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). |
| |
| Mohs Surgery | Previously completed treatment for non-melanoma skin cancer using Mohs Surgery: Uniquely orients, maps, and processes removed tissue, permitting the microscopic evaluation of virtually 100% of the specimen margins. The completeness of this margin control permits the accurate identification and removal of all tumor extensions under the microscope. Tissues in Mohs surgery are processed as modified frozen sections which allow the accurate and rapid interpretation of most skin cancers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Brachytherapy | Procedure | A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site. | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS. | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. |
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Inclusion Criteria:
Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;
Provides informed Consent;
Greater than 40 years of age;
Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;
Cancer Staging included in this study:
Exclusion Criteria:
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Up to 320 subjects treated with eBx and up to 320 subjects treated with Mohs surgery will have data collected retrospectively from the patient's medical records, and prospectively at the time of the follow-up visit for those who agree to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Patel, MD | Good Samaritan Radiation Oncology | Principal Investigator |
| Robert Strimling | Strimling Dermatology, Laser, and Vein Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenneth A. Miller, PC | Los Gatos | California | 95032 | United States | ||
| Dermatology & Laser Center of San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28951753 | Result | Patel R, Strimling R, Doggett S, Willoughby M, Miller K, Dardick L, Mafong E. Comparison of electronic brachytherapy and Mohs micrographic surgery for the treatment of early-stage non-melanoma skin cancer: a matched pair cohort study. J Contemp Brachytherapy. 2017 Aug;9(4):338-344. doi: 10.5114/jcb.2017.68480. Epub 2017 Jun 23. |
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N/A This is a retrospective-prospective study design.
Identify and collect any existing data from the patients record and conduct office visits on patients with non-melanoma skin cancer who underwent treatment with either eBx or Mohs and completed treatment approximately 3 yrs prior (range of 2-4 years) to asses long-term outcomes of treated areas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mohs Surgery | Previously completed treatment for non-melanoma skin cancer using Mohs Surgery |
| FG001 | Electronic Brachytherapy | Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Brachytherapy | Previously completed treatment of 1 or more non-melanoma skin cancer lesions per participant using Xoft eBx Electronic Brachytherapy System |
| BG001 | Mohs Surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site. | Posted | Number | participants | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Lesions Analyzed | Lesions Analyzed |
|
Patients have been followed for 2.6 to 4.3 years after EBT, and 2.3 to 5 years following MMS.
All additional adverse events that were collected have been reported. The only adverse events reported were all skin toxicities from CTCAE.
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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 | Mohs Surgery | Previously completed treatment for non-melanoma skin cancer using Mohs Surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Late toxicities | Skin and subcutaneous tissue disorders | Systematic Assessment | hypopigmentation, hyperpigmentation, erythematous car, telangiectasia, hair loss, fibrosis, atrophy, loss of subcutaneous tissue, hypertrophy/keloid, poor healing/ulceration/erosion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Burnside | Xoft Inc. | 14084931533 | rob.burnside@elekta.com |
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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 | Mar 7, 2017 | Dec 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015580 | Mohs Surgery |
| ID | Term |
|---|---|
| D008866 | Microsurgery |
| D013514 | Surgical Procedures, Operative |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
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|
|
| Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS. | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. |
| Chronic Toxicities | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS. | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. |
| Patient Survey for Reporting Patient Reported Outcomes (PRO) | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response. | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion. |
| San Diego |
| California |
| 91910 |
| United States |
| Dermatology and Laser Center of San Diego | San Diego | California | 92103 | United States |
| Strimling Laser and Vein Institute | Las Vegas | Nevada | 89144 | United States |
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
| BG002 | Total | Total of all reporting groups |
| Lesions Analyzed |
|
| years |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Lesions by Size | 0 ≤1cm 0 >1cm and ≤2cm 0 >2cm and >2cm 0 N/A | Number | lesions | Lesions Analyzed |
|
| OG001 | Mohs Surgery | Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC. |
|
|
| Secondary | Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS. | Posted | Number | lesions | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Lesions Analyzed | Lesions Analyzed |
|
|
|
| Secondary | Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS. | Posted | Number | lesions | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Lesions Analyzed | Lesions Analyzed |
|
|
|
| Secondary | Chronic Toxicities | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS. | Analysis same as late toxicities. | Posted | Count of Units | Lesions Analyzed | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Lesions Analyzed | Lesions Analyzed |
|
|
|
| Secondary | Patient Survey for Reporting Patient Reported Outcomes (PRO) | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response. | Posted | Mean | Standard Deviation | score on a scale | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion. |
|
|
|
| 0 |
| 181 |
| 0 |
| 181 |
| 79 |
| 181 |
| EG001 | Electronic Brachytherapy | Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System | 0 | 188 | 0 | 188 | 107 | 188 |
|
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