Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT07234461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual well-being', 'timeFrame': 'Enrollment visit', 'description': 'Sexual well-being, a multidimensional construct, will be assessed using a combination of validated and non-validated questionnaires. For each outcome score, descriptive statistics will be reported, including mean, standard deviation, median, and interquartile range. Comparisons of mean scores across predefined subgroups-such as type of reconstruction, systemic and local treatments, menopausal status, obesity, and parity-will be conducted using analysis of variance. A p-value \\< 0.05 will be considered statistically significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mastectomy and Breast Reconstruction', 'Sexual Wellness']}, 'descriptionModule': {'briefSummary': 'The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys.\n\nThis data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments.\n\nSpecific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy).\n\nOur goal is to improve quality of life of breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing mastectomy for primary breast cancer;\n* High-risk healthy patients undergoing risk reducing mastectomies;\n* Unilateral and/or bilateral mastectomies;\n* If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;\n* All reconstructive procedures included (autologous and heterologous reconstructions).\n\nExclusion Criteria:\n\n* Patients undergoing breast conservation;\n* Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;\n* Delayed post-mastectomy reconstructions;\n* Patients not available for e-correspondence.'}, 'identificationModule': {'nctId': 'NCT07234461', 'briefTitle': 'Sexual Well-being of Women Undergoing Mastectomy and Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.', 'orgStudyIdInfo': {'id': 'UID 4897'}, 'secondaryIdInfos': [{'id': 'L2-367', 'type': 'OTHER', 'domain': 'Comitato Etico Territoriale Lombardia 2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Survey', 'description': 'At 1-year follow-up, breast cancer patients who underwent mastectomy and reconstruction are asked to complete several questionnaires after the medical consultation collecting sociodemographic information and their sexual well-being.', 'interventionNames': ['Other: Survey using a questionnaire.']}], 'interventions': [{'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'Questionnaires collecting sociodemographic information and their sexual well-being.', 'armGroupLabels': ['Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Angela Gurrado, MD', 'role': 'CONTACT', 'email': 'urp.policlinico.bari@pec.rupar.puglia.it', 'phone': '+39 080 919 8749'}, {'name': 'Angela Gurrado, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Consorziale Policlinico', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70124', 'city': 'Bari', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Daniela Anna Cutrignelli, MD', 'role': 'CONTACT', 'email': 'd.cutrignelli@oncologico.bari.it', 'phone': '+39 0805555917'}, {'name': 'Daniela Anna Cutrignelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Tumori Giovanni Paolo II', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Chiara Gelati, MD', 'role': 'CONTACT', 'email': 'angela.sandoni@aosp.bo.it', 'phone': '+39 051 2143614'}, {'name': 'Chiara Gelati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Policlinico Sant'Orsola-Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '47521', 'city': 'Cesena', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Rossella Sgarzani, MD', 'role': 'CONTACT', 'email': 'rossella.sgarzani2@unibo.it', 'phone': '+39 0547 352111'}, {'name': 'Rossella Sgarzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Bufalini di Cesena', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'zip': '47121', 'city': 'Forlì', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Curcio, MD', 'role': 'CONTACT', 'email': 'curcioannalisa@hotmail.it', 'phone': '+39 0543731676'}, {'name': 'Annalisa Curcio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio Ospedaliero GB Morgagni-Pierantoni', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '20141', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Francesca De Lorenzi, MD', 'role': 'CONTACT', 'email': 'francesca.delorenzi@ieo.it', 'phone': '+39 0257489.394'}, {'name': 'Francesca De Lorenzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '07026', 'city': 'Olbia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Sonia Bove, MD', 'role': 'CONTACT', 'email': 'sonia.bove@materolbia.com', 'phone': '+39 0789 18999'}, {'name': 'Sonia Bove, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Mater Olbia', 'geoPoint': {'lat': 40.92337, 'lon': 9.49802}}, {'zip': '35128', 'city': 'Padua', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Laura Pandis, MD', 'role': 'CONTACT', 'email': 'chir.plastica@aopd.veneto.it', 'phone': '+39 0498212768'}, {'name': 'Laura Pandis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedale Università di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '90127', 'city': 'Palermo', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Adriana Cordova, MD', 'role': 'CONTACT', 'email': 'adriana.cordova@policlinico.pa.it', 'phone': '+39 091 655 34 00'}, {'name': 'Adriana Cordova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Adele Sgarella, MD', 'role': 'CONTACT', 'email': 'a.sgarella@smatteo.pv.it', 'phone': '+39 0382502288'}, {'name': 'Adele Sgarella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '56100', 'city': 'Pisa', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Manuela Roncella, MD', 'role': 'CONTACT', 'email': 's.palmiero@ao-pisa.toscana.it', 'phone': '+39 050992729'}, {'name': 'Manuela Roncella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00128', 'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Barbara Cagli, MD', 'role': 'CONTACT', 'email': 'b.cagli@unicampus.it', 'phone': '+39 06 9762 0968'}, {'name': 'Barbara Cagli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00144', 'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Lucia Mangialardi, MD', 'role': 'CONTACT', 'email': 'segreteria.drmangialardi@gmail.com', 'phone': '+39 351 319 1190'}, {'name': 'Lucia Mangialardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Tumori Regina Elena', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Marzia Salgarello, MD', 'role': 'CONTACT', 'email': 'marzia.salgarello@policlinicogemelli.it', 'phone': '+39 06 3015.4667'}, {'name': 'Marzia Salgarello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Maria Alessandra Bocchiotti, MD', 'role': 'CONTACT', 'email': 'mariaalessandra.bocchiotti@unito.it', 'phone': '+39 0116336991'}, {'name': 'Maria Alessandra Bocchiotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della salute e della scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '31100', 'city': 'Treviso', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Elisa Antoniazzi, MD', 'role': 'CONTACT', 'email': 'segchgen3tv@aulss2.veneto.it', 'phone': '+39 0422 322372'}, {'name': 'Elisa Antoniazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Treviso', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'zip': '34149', 'city': 'Trieste', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Nadia Renzi, MD', 'role': 'CONTACT', 'email': 'nadia.renzi@asugi.sanita.fvg.it', 'phone': '+39 040 3994258'}, {'name': 'Nadia Renzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale di Cattinara', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '33100', 'city': 'Udine', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Glenda Caputo, MD', 'role': 'CONTACT', 'email': 'urp@policlinicoudine.it', 'phone': '+39 0432 559432'}, {'name': 'Glenda Caputo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Universitario di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '21100', 'city': 'Varese', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Francesca Rovera, MD', 'role': 'CONTACT', 'email': 'francesca.rovera@uninsubria.it', 'phone': '+39 0332 278111'}, {'name': 'Francesca Rovera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Breast Unit Settelaghi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Francesca De Lorenzi, MD', 'role': 'CONTACT', 'email': 'francesca.delorenzi@ieo.it', 'phone': '+39 0257489.394'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}