Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:40 AM
Study NCT ID:
NCT04555395
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Differences Between Gonadal and Extra-gonadal Malignant Teratomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015996', 'term': 'Survival Rate'}], 'ancestors': [{'id': 'D009026', 'term': 'Mortality'}, {'id': 'D014798', 'term': 'Vital Statistics'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3799}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1973-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rates', 'timeFrame': '1973-2014'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SEER Database']}, 'descriptionModule': {'briefSummary': 'A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. We have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders.\n\nMethods: The samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. Trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. The fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) \\< Katrina/Rita Population Adjustment\\> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) \\< Katrina/Rita Population Adjustment\\> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.'}, 'identificationModule': {'nctId': 'NCT04555395', 'briefTitle': 'The Differences Between Gonadal and Extra-gonadal Malignant Teratomas', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'The Differences Between Gonadal and Extra-gonadal Malignant Teratomas in Both Genders and the Effects of Chemotherapy', 'orgStudyIdInfo': {'id': 'malignant teratomas'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gonadal', 'interventionNames': ['Other: survival rates']}, {'label': 'extra-gonadal', 'interventionNames': ['Other: survival rates']}, {'label': 'chemotherapy', 'interventionNames': ['Other: survival rates']}, {'label': 'without chemotherapy', 'interventionNames': ['Other: survival rates']}], 'interventions': [{'name': 'survival rates', 'type': 'OTHER', 'description': 'survival rates', 'armGroupLabels': ['chemotherapy', 'extra-gonadal', 'gonadal', 'without chemotherapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Shanghai 10th People's Hospital", 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}