Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04805905
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2021-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '12 months', 'description': 'Percent of patients who are recruited for the feasibility study'}, {'measure': 'Retention rate', 'timeFrame': '3 months from surgery', 'description': 'The number of patients who complete the secondary outcomes (FACE-Q scores) at 3 months'}, {'measure': 'Compliance rate', 'timeFrame': '12 months', 'description': 'Compliance rate of patients receiving a treatment and completing the expected treated'}, {'measure': 'Eligible patients', 'timeFrame': '12 months', 'description': 'Percent of patients who meet eligibility criteria for the feasibility study'}], 'secondaryOutcomes': [{'measure': 'FACE-Q score', 'timeFrame': '12 months', 'description': "FACE-Q is a recently developed and validated patient reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after skin cancer surgery of the face.The PROM is used to assess the perspective and impact of skin cancer as well as its treatment on the patient's quality of life (QoL). Patients with skin cancer may have increased anxiety, social isolation, and cosmetic concerns after surgery. The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. Raw scores are transformed to a 0-100 scale with a higher score indicating a better outcome"}, {'measure': 'Facial photos', 'timeFrame': '12 months', 'description': 'Patient photos will be taken post-op at 2 weeks, 3 months, 6 months, and one-year post-operation, if feasible'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Cancer, Basal Cell', 'Skin Cancer', 'Skin Cancer, Non-Melanoma', 'Skin Cancers - Squamous Cell Carcinoma', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).', 'detailedDescription': 'A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).\n\nUpon completion of the feasibility study, a prospective pilot cohort study would be performed to measure outcomes using the FACE-Q Skin Cancer module for patients receiving skin grafting or local flaps after excision of facial skin cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be included in the study if they are 18 years or older, presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis), and scheduled to undergo reconstruction with either a skin graft or local tissue flap. Patients will be excluded in the study if they: present with altered level of consciousness, cannot provide consent, have facial nerve injury/previous facial nerve injury, have Melanoma skin cancer or Merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be included in the study if:\n\n* they are 18 years or older\n* presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis),\n* and scheduled to undergo reconstruction with either a skin graft or local tissue flap.\n\nExclusion Criteria:\n\nPatients will be excluded in the study if they:\n\n* present with altered level of consciousness,\n* cannot provide consent,\n* have facial nerve injury/previous facial nerve injury, have Melanoma skin cancer or Merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.'}, 'identificationModule': {'nctId': 'NCT04805905', 'briefTitle': 'A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study', 'orgStudyIdInfo': {'id': '8304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Skin graft', 'interventionNames': ['Other: FACE-Q patient reported outcome']}, {'label': 'Local flap', 'interventionNames': ['Other: FACE-Q patient reported outcome']}], 'interventions': [{'name': 'FACE-Q patient reported outcome', 'type': 'OTHER', 'description': 'As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group.\n\nSkin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient\'s face along with the distributed questionnaires.\n\nLocal flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.', 'armGroupLabels': ['Local flap', 'Skin graft']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mark McRae', 'role': 'CONTACT', 'email': 'Mcraem2@mcmaster.ca', 'phone': '(905) 522-1155 x32145', 'phoneExt': '32145'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark McRae', 'investigatorAffiliation': 'McMaster University'}}}}