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The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.
This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up.
The study will include:
Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMSC Treatment | Patients who completed Xoft eBx treatment at least five years from the last treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xoft eBx | Device | The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence | Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site. | Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Toxicities | Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site. |
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Inclusion Criteria:
Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0
Exclusion Criteria:
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The first phase of this study will be to identify patients who completed treatment with eBx at least five years ago prior to study onset and collect history and demographic data, and eligibility data retrospectively from the patient records and on source worksheets.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Doggett, MD | Mission Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenneth A. Miller, MD Dermatology | Campbell | California | 95032 | United States | ||
| Dermatology & Laser Center of San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36970438 | Result | Doggett SW, Willoughby M, Miller KA, Mafong E. Long-term clinical outcomes of non-melanoma skin cancer patients treated with electronic brachytherapy. J Contemp Brachytherapy. 2023 Feb;15(1):9-14. doi: 10.5114/jcb.2023.125580. Epub 2023 Feb 28. |
| Label | URL |
|---|---|
| Long-term clinical outcomes of non-melanoma skin cancer patients treated with electronic brachytherapy | View source |
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No plan not sharing IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | NMSC Treatment | Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with eBx Treatment that completed at least 5 Year Follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | NMSC Treatment | Retrospective review to find subjects post Xoft eBx treatment completed at least 5 years ago to complete 1 long-term prospective visit. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source |
| 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 | Local Recurrence | Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site. | 180 Patients that completed eBx treatment with at least 5 Year follow-up | Posted | Count of Units | Lesions | Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. | Lesions | Lesions |
|
Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.
Select Skin toxicity adverse events according to 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 | NMSC Treatment | Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypopigmentation Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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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 | Dec 28, 2021 | Dec 9, 2022 | Prot_SAP_000.pdf |
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| Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. |
| San Diego |
| California |
| 91910 |
| United States |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Skin Toxicities | Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site. | Patients who completed Xoft eBx treatment at least five year follow-up | Posted | Count of Participants | Participants | Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| 129 |
| 180 |
| Telangiectasia Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scar Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperpigmentation Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Induration Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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