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Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery

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ClinicalTrials.gov Identifier: NCT03024866
Recruitment Status : Unknown
Verified January 2017 by Xoft, Inc..
Recruitment status was:  Recruiting
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
Xoft, Inc.

Brief Summary:
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.

Condition or disease
Nonmelanoma Skin Cancer

Detailed Description:

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:

  1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC.
  2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery
Study Start Date : October 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Group/Cohort
Electronic Brachytherapy
Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Mohs Surgery
Previously completed treatment for non-melanoma skin cancer using Mohs Surgery



Primary Outcome Measures :
  1. Absence of local recurrence at approximately 3 to 5-year follow-up (range is approximately two to five years) at treatment site(s). [ Time Frame: Two to five years post treatment ]
    Assessment of treatment site 2-5 years following treatment to determine if recurrence


Secondary Outcome Measures :
  1. Comparison of long-term toxicities related to eBx vs. Mohs treatment Using A Chronic Toxicity Questionnaire Based om Physician Assessment at Time of Visit [ Time Frame: Two to five years post treatment ]
    Assessment of treatment site 2-5 years following treatment to determine if long-term toxicity

  2. Comparison of long-term cosmetic outcomes for lesions treated for NMSC with eBx vs. Mohs; [ Time Frame: Two to five years post treatment ]
    Physician assessment of cosmetic outcome two to five years post treatment, at time of clinic visit.

  3. Chronic toxicities [ Time Frame: Two to five years post treatment ]
    Physician assessment of treatment site to assess for chronic toxicites two to five years post treatment, at time of clinic visit.

  4. Patient Survey for reporting Patient Reported Outcomes (PRO) [ Time Frame: Two to five years post treatment ]
    Patient completes a survey at a clinic visit two to five years post treatment at time of clinic visit



Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;
  2. Provides informed Consent;
  3. Greater than 40 years of age;
  4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;
  5. Cancer Staging included in this study:

    • Stage 0: Tis, N0, M0
    • Stage 1: T1, N0, M0
    • Stage 2: T2, N0, M0 and ≤ 4cm in diameter

Exclusion Criteria:

  1. Target area is adjacent to a burn scar
  2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment
  3. Known perineural invasion
  4. Actinic Keratosis
  5. Known spread to regional lymph nodes
  6. Known metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024866


Contacts
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Contact: John DeLucia 603-546-7430 jdelucia@icadmed.com
Contact: Joyce Musacchio 603-882-5200 ext 7308 jmusacchio@icadmed.com

Locations
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United States, California
Kenneth A. Miller, PC Active, not recruiting
Los Gatos, California, United States, 95032
Dermatology & Laser Center of San Diego Recruiting
San Diego, California, United States, 91910
Contact: Mark Willoughby, MD    619-754-8469    willoughby_mark@hotmail.com   
Dermatology and Laser Center of San Diego Recruiting
San Diego, California, United States, 92103
Contact: Mark Willoughby, MD    619-320-4807    willoughby_mark@hotmail.com   
United States, Nevada
Strimling Laser and Vein Institute Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jamie Butler    702-243-6400      
Sponsors and Collaborators
Xoft, Inc.
Eminence Clinical Research, Inc.
Investigators
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Principal Investigator: Rakesh Patel, MD Good Samaritan Radiation Oncology
Principal Investigator: Robert Strimling Strimling Dermatology, Laser, and Vein Institute

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Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT03024866     History of Changes
Other Study ID Numbers: CTPR-0014
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases