Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT05873361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002291', 'term': 'Carcinoma, Papillary'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'Review of medical record'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': '10 years', 'description': 'No recurrence clinically detected or by additional examen'}, {'measure': 'Surgical complications rate', 'timeFrame': '10 years', 'description': 'Dysphonia and hypocalcemia'}, {'measure': 'Detection of recurrence rate', 'timeFrame': '10 years', 'description': 'Recurrence detection by additional examen'}, {'measure': 'Recovery surgical or iratherapie recovery rate', 'timeFrame': '10 years', 'description': 'Anatomopathologic analysis'}, {'measure': 'Anxiety evaluation', 'timeFrame': '1 month', 'description': 'Likert scale'}, {'measure': 'Prognostics survival criteria', 'timeFrame': '1 month', 'description': 'Age during surgical'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Papillary Carcinoma', 'Postoperative', 'Follow-up'], 'conditions': ['Papillary Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a study assessing the interest of post-operative follow-up of asymptomatic papillary microcarcinomas. Today, this post-operative follow-up represents an economic cost and is a source of anxiety for patients.\n\nThe aim of this study is to determine the global survival of patients with asymptomatic papillary microcarcinoma to assess the interest of a post-operative ultrasound and/or biological follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with papillary microcarcinoma asymptomatic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with uni or multifocal papillary microcarcinoma (cumulative size of foci \\<10mm) asymptomatic or not and who underwent partial or total thyroidectomy from 2012 to 2017.\n* Non opposition patient\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Lesion crossing the thyroid capsule, or cervical lymph node involvement clinical or histological cervical lymph node involvement.\n* Patient under guardianship, curators or safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05873361', 'acronym': 'MIPTHYS', 'briefTitle': 'Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Interest of Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival', 'orgStudyIdInfo': {'id': 'RC31/23/0059'}, 'secondaryIdInfos': [{'id': '2023-A00294-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with a papillary microcarcinoma asymptomatic', 'description': 'Adult patients who have had a papillary microcarcinoma asymptomatic and who are followed.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The questionnaire is about hypocalcemia, dysphonia and anxiety. It will be carried out by phone call for 10 minutes', 'armGroupLabels': ['Adult patients with a papillary microcarcinoma asymptomatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Agnès DUPRET-BORIES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}