RECRUITING

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. Prevention of SCC's in the RDEB subjects will increase their life span.

Official Title

Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin

Quick Facts

Study Start:2025-03-28
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06731933

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
  2. 2. Presence of biopsy proven squamous cell carcinoma (SCC)
  3. 3. Ability to understand and the willingness to provide written informed consent.
  4. 4. US based participants are willing to use beremagene geperpavec (BVEC)
  5. 5. Subject is 18 years or older
  6. 6. participant willingness to use an effective method of contraception
  1. 1. Inability to travel to site for study visit
  2. 2. Subject is pregnant
  3. 3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Contacts and Locations

Study Contact

Kunju Sridhar
CONTACT
650-721-4902
kunju@stanford.edu

Principal Investigator

Peter Marinkovich, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Redwood City, California, 94063
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Peter Marinkovich, MD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Registration Dates

Study Start Date2025-03-28
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-03-28
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • gene therapy

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma