Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 12:07 PM
Study NCT ID:
NCT05907551
Status:
UNKNOWN
Last Update Posted:
2023-08-22
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs", 'timeFrame': 'at inclusion', 'description': '4 items questionnaires'}, {'measure': "Describe patients' knowledges regarding dermo-cosmetics and aesthetic solutions that can attenuate cutaneous side-effects, nail and hair toxicities induced by anticancer drugs", 'timeFrame': 'at inclusion', 'description': '10 items questionnaires'}], 'secondaryOutcomes': [{'measure': "Describe patients' socio-economic profile to assess equity regarding access to dermo-cosmetics and aesthetic solutions", 'timeFrame': 'at inclusion', 'description': '11 items questionnaires'}, {'measure': "Correlate patients' knowledge level depending on tumoral location", 'timeFrame': 'at inclusion', 'description': 'Tumoral location as described in medical chart'}, {'measure': "Correlate patients' knowledge level depending on received treatment", 'timeFrame': 'at inclusion', 'description': 'Type of chemotherapy administered on the day of inclusion as described in medical chart'}, {'measure': "Correlate patients' knowledge level depending on treatment phase", 'timeFrame': 'at inclusion', 'description': 'Type of treatment phase (i.e. neoadjuvant, adjuvant, 1st or 2nd metastatic line) as described in medical chart'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': "Cancer treatments can trigger cutaneous side-effects, as well as nail and hair toxicities. When related to drug treatment, this iatrogeny depends on the type of drug, its dosage and individual susceptibility. Although these dermatological adverse events are rarely serious, they can significantly alter patients' quality of life, and may even necessitate the introduction of curative treatment.\n\nThe impact of these side effects can be mitigated by the use of dermo-cosmetic products and aesthetic solutions. However, most of this supportive care is not reimbursed by the health insurance system, representing a source of inequalities in access to healthcare for cancer patients.", 'detailedDescription': "This study aims at establishing, in a cohort of patients with solid tumors, the state of their knowledges, given information and their financial capacities regarding access to dermo-cosmetics and aesthetic solutions, that are used in the attenuation of cancer treatments' side-effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll patients with solid tumors in 7 different cohorts according to tumor location (30 patients per location)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients with solid tumors (eligible localization include: digestive system, Head and Neck, Breast, Brain, Lung Tumors, Urological and Gynecologic cancers)\n* Patients able to read and understand French\n* Patients that has expressed their consent and with signed consent form\n\nExclusion Criteria:\n\n* Minor or patients placed under guardianship or supervision\n* Patients unable to read French\n* Patients placed under judicial protection'}, 'identificationModule': {'nctId': 'NCT05907551', 'acronym': 'DERMOCOS', 'briefTitle': 'Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions', 'orgStudyIdInfo': {'id': '2023-001'}, 'secondaryIdInfos': [{'id': '2023-A00546-39', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Digestive System Cancer', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Head and Neck Cancer', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Breast Cancer', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Nervous System Tumors', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Urological Cancer', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Lung Cancer', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Patients with Gynecologic Cancer', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': '25-items questionnaire', 'armGroupLabels': ['Patients with Breast Cancer', 'Patients with Digestive System Cancer', 'Patients with Gynecologic Cancer', 'Patients with Head and Neck Cancer', 'Patients with Lung Cancer', 'Patients with Nervous System Tumors', 'Patients with Urological Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nelly ETIENNE-SELLOUM, PharmD', 'role': 'CONTACT'}], 'facility': 'Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Manon VOEGELIN', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)3 68 33 95 23', 'phoneExt': '33'}, {'name': 'Claire VIT', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)3 88 25 85 29'}], 'overallOfficials': [{'name': 'Nelly ETIENNE-SELLOUM, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut de cancérologie Strasbourg Europe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}