Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06308016
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of risk factors', 'timeFrame': '12 months', 'description': 'The primary objective of the project is the identification of pre-operative risk factors'}], 'secondaryOutcomes': [{'measure': 'Stratify patients', 'timeFrame': '12 months', 'description': 'The secondary objective is to construct a score to stratify patients according to the risk of developing PCF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngeal Cancer']}, 'descriptionModule': {'briefSummary': 'Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.', 'detailedDescription': 'Evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk PCF pharyngocutaneous fistula.\n\nAnalyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx\n\nThe results obtained from the present study will allow patients to be stratified into low and high risk for PCF to undergo total laryngectomy, so as to reduce this surgical complication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For the present study, data relating to patients who, in a manner, will be analyzed retrospectively consecutive, I meet the following criteria.\n\nAll patients underwent procedures and/or diagnostic-therapeutic procedures, as well as tests and assessments as required by guidelines and/or conventional clinical management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing LT surgery with direct closure of the pharynx in case of:\n\n* naïve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);\n* recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);\n* recurrence of laryngeal neoplasm after RT or Ch-RT treatment;\n* lack of functionality of the larynx induced by (Ch-)RT treatment;\n* Availability of data according to the assessments that will have to be made, including a FU period of 2 months.\n\nExclusion Criteria:\n\n* Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.'}, 'identificationModule': {'nctId': 'NCT06308016', 'briefTitle': 'Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Study of the Risk of Pharyngocutaneous Fistula (PCF) in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification (Fistula-score)', 'orgStudyIdInfo': {'id': '25/IRE/23'}}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raul Pellini, MD', 'role': 'CONTACT', 'email': 'raul.pellini@ifo.it', 'phone': 'ND'}, {'name': 'Francesco Mazzola, Doctor', 'role': 'CONTACT', 'email': 'francesco.mazzola@ifo.it', 'phone': '06 5266 4485'}], 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Raul Pellini, Doctor', 'role': 'CONTACT', 'email': 'raul.pellini@ifo.it', 'phone': '06 5266 6765'}, {'name': 'Francesco Mazzola, Doctor', 'role': 'CONTACT', 'email': 'francesco.mazzola@ifo.it', 'phone': '06 5266 4485'}], 'overallOfficials': [{'name': 'Raul Pellini, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS "Regina Elena" National Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}