Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-04 @ 12:26 AM
Study NCT ID:
NCT06731933
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2024-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of Squamous Cell Carcinoma', 'timeFrame': '2 years', 'description': 'The outcome measure is recurrence rate of SCC following BVEC application at each SCC lesion'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gene therapy'], 'conditions': ['Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "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.\n\nPrevention of SCC's in the RDEB subjects will increase their life span."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations\n2. Presence of biopsy proven squamous cell carcinoma (SCC)\n3. Ability to understand and the willingness to provide written informed consent.\n4. US based participants are willing to use beremagene geperpavec (BVEC)\n5. Subject is 18 years or older\n6. participant willingness to use an effective method of contraception\n\nExclusion Criteria:\n\n1. Inability to travel to site for study visit\n2. Subject is pregnant\n3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC."}, 'identificationModule': {'nctId': 'NCT06731933', 'briefTitle': 'Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin', 'orgStudyIdInfo': {'id': 'IRB-73906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment with BVEC', 'interventionNames': ['Drug: BVEC']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment with BVEC'}], 'interventions': [{'name': 'BVEC', 'type': 'DRUG', 'otherNames': ['Beremagene Geperpavec'], 'description': 'The study drug will be administered by home nurse at Subjects home for the participants residing in US. No drug will be applied when at study site. The subjects enrolled in Bari, Italy will not be administered BVEC.', 'armGroupLabels': ['Treatment with BVEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kunju Sridhar', 'role': 'CONTACT', 'email': 'kunju@stanford.edu', 'phone': '650-721-4902'}, {'name': 'Peter M Marinkovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Lospalluti, MD', 'role': 'CONTACT', 'email': 'l.lospalluti@gmail.com', 'phone': '080-5592442'}, {'name': 'Lucia Lospalluti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedliero-Universitaia', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Kunju Sridhar', 'role': 'CONTACT', 'email': 'kunju@stanford.edu', 'phone': '650-721-4902'}], 'overallOfficials': [{'name': 'Peter Marinkovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epidermolysis Bullosa Research Partnership', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}