Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05637892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-08
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of Hydatidiform Mole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006828', 'term': 'Hydatidiform Mole'}], 'ancestors': [{'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}, {'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collect blood, and tissue samples from patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malignant trophoblastic tumor', 'timeFrame': '4.5 years', 'description': 'Patients with hydatidiform mole develop malignant trophoblastic tumor. The Federation of International of Gynecologists and Obstetricians criteria for diagnosis of postmolar gestational trophoblastic neoplasia were as follows: (1) when the plateau of human chorionic gonadotrophin (hCG) lasts for four measurements over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; (2) when there is a rise in hCG for three consecutive weekly measurements over at least a period of 2 weeks or more; days 1, 7, 14; (3) If there is a histologic diagnosis of choriocarcinoma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hydatidiform Mole']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to construct a cohort for the hydatidiform mole.', 'detailedDescription': 'After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Outpatient or inpatient patients in women's hospital school medicine of zhejiang university and other cooperative hospitals (including tongji hosptial, tongji medical college of hust, qilu hosptial of shandong university, Sun Yat-sen university cancer center) were inclued in this cohort study if the patients met the eligibility requirements and agreed to participate in this study", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are diagnosed with hydatidiform mole (including: complete hydatidiform mole/partial hydatidiform mole; one of twins with hydatidiform mole; ectopic pregnancy hydatidiform mole; macroscopic or microscopic hydatidiform changes indicating early complete or partial hydatidiform mole can not be excluded; atypical placental site nodule) for the first time;\n2. Age 13-55 years old;\n3. Obtain informed consent and sign an informed consent form\n\nExclusion Criteria:\n\n1. Patients who are unable to cooperate with the investigation such as mental disorders or cognitive impairment\n2. No histopathology diagnosis;\n3. Patients with other malignancies'}, 'identificationModule': {'nctId': 'NCT05637892', 'briefTitle': 'A Cohort Study of Hydatidiform Mole', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'A Multi-center Cohort Study of Hydatidiform Mole', 'orgStudyIdInfo': {'id': 'IRB-20220312-R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is a prospective observational study with no intervention'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weiguo Lv, PhD', 'role': 'CONTACT', 'email': 'lbwg@zju.edu.cn', 'phone': '13588819218'}, {'name': 'Xiao Li, PhD', 'role': 'CONTACT', 'email': '5198009@zju.edu.cn', 'phone': '13958160137'}], 'overallOfficials': [{'name': 'Weiguo Lv, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Hospital School Of Medicine Zhejiang University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}