Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07204535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Traumatic Stress Disorder evaluation', 'timeFrame': 'at 2 months', 'description': 'Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32'}], 'secondaryOutcomes': [{'measure': 'Anxiety and Depression', 'timeFrame': 'until 60 months', 'description': 'Hospital Anxiety and Depression scale'}, {'measure': 'Quality of Life (general module)', 'timeFrame': 'until 60 months', 'description': 'Evaluated with EORTC QLQ-C30 questionnaire'}, {'measure': 'Quality of Life (cervical cancer module)', 'timeFrame': 'until 60 months', 'description': 'Evaluated with EORTC QLQ-CX24 questionnaire'}, {'measure': 'Sexual Health evaluation', 'timeFrame': 'until 60 months', 'description': 'Sexual Health Questionnaire (EORTC SHQ-22)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachytherapy', 'Post-TRaUmatic STress Disorder', 'Cervical cancer'], 'conditions': ['Uterine Cervical Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical cancer using self-administered questionnaires. The study also aims to assess the persistence of these symptoms over time, up to 5 years after brachytherapy. The results could help identify patients at risk of post-traumatic stress in this context and develop appropriate psychological interventions to improve their psychological well-being during and after treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy;\n* Squamous cell carcinoma or other histological types;\n* WHO ≤ 2;\n* Ability to complete validated questionnaires in French;\n* Informed consent to participate in the study;\n* Patients over 18 years old\n\nExclusion Criteria:\n\n* Inability to understand or respond to questionnaires due to a cognitive disorder, intellectual disability, language barrier, or psychiatric disorder that impairs judgment;\n* Patient under juridic protection;\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT07204535', 'acronym': 'TRUST-GB', 'briefTitle': 'Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Paul Strauss'}, 'officialTitle': 'Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy', 'orgStudyIdInfo': {'id': '2024-004'}, 'secondaryIdInfos': [{'id': '2025-A00672-47', 'type': 'OTHER', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with cervical cancer with an indication for uterovaginal brachytherapy', 'interventionNames': ['Other: Prospective questionnaires']}], 'interventions': [{'name': 'Prospective questionnaires', 'type': 'OTHER', 'description': 'Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires', 'armGroupLabels': ['Patient with cervical cancer with an indication for uterovaginal brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'George NOEL, MD, PhD', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '368766767', 'phoneExt': '33'}], 'facility': 'ICANS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Valérie SARTORI', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '368767223', 'phoneExt': '33'}, {'name': 'Claire VIT', 'role': 'CONTACT', 'email': 'c.vit@icans.eu', 'phone': '388258529', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'George NOEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICANS, CPS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Paul Strauss', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}