Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:15 AM
Study NCT ID:
NCT06207812
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2024-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017731', 'term': 'Lymphomatoid Papulosis'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and adverse events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphomatoid Papulosis', 'Mycosis Fungoides']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.', 'detailedDescription': 'Primary Objective -To characterize the long-term outcomes associated with juvenile-onset mycosis fungoides (jMF) and lymphomatoid papulosis (lyp). The study will consider metrics such as 5-year and 10-year overall survival, and overall disease activity.\n\nSecondary objective\n\n-To characterize treatments and associated comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with juvenile-onset mycosis fungoides', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-To be eligible, participants had to be diagnosed with jMF or lyp before age 20. In the case of participants below the age of 18, parents and not the children will be contacted for participation (children are exempt from participation as their parents may answer our study questions).\n\nExclusion Criteria:\n\n-Participants older than 20 years of age at diagnosis'}, 'identificationModule': {'nctId': 'NCT06207812', 'briefTitle': 'Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis', 'orgStudyIdInfo': {'id': '2023-0745'}, 'secondaryIdInfos': [{'id': 'NCI-2024-00109', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Dai, MD', 'role': 'CONTACT', 'email': 'jdai6@mdanderson.org', 'phone': '713-515-7961'}, {'name': 'Julia Dai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Julia Dai, MD', 'role': 'CONTACT', 'email': 'jdai6@mdanderson.org', 'phone': '(713) 515-7961'}], 'overallOfficials': [{'name': 'Julia Dai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}