Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 4:56 PM
Study NCT ID:
NCT06620068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causal Relationship Between Plasma VEGF Family Proteins and Placenta Previa: A Two-Sample Mendelian Randomization Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The study utilizes genome-wide association study (GWAS) data from publicly available biobanks (e.g., UK Biobank and FinnGen), which include samples with DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207473}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Causal relationship between plasma VEGFA levels and the risk of placenta previa', 'timeFrame': 'Data analysis and outcome assessment will be completed by December 2024', 'description': 'This outcome measures the association between plasma VEGFA levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.'}], 'secondaryOutcomes': [{'measure': 'Causal relationship between plasma VEGFB levels and the risk of placenta previa', 'timeFrame': 'Data analysis and outcome assessment will be completed by December 2024', 'description': 'This outcome measures the association between plasma VEGFB levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.'}, {'measure': 'Causal relationship between plasma VEGFC levels and the risk of placenta previa', 'timeFrame': 'Data analysis and outcome assessment will be completed by December 2024', 'description': 'This outcome measures the association between plasma VEGFC levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.'}, {'measure': 'Causal relationship between plasma PLGF levels and the risk of placenta previa', 'timeFrame': 'Data analysis and outcome assessment will be completed by December 2024', 'description': 'This outcome measures the association between plasma PLGF levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Endothelial Growth Factor (VEGF)', 'Mendelian Randomization', 'Angiogenesis', 'Pregnancy Complications', 'Placental Development'], 'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the causal relationship between plasma vascular endothelial growth factor (VEGF) family proteins and placenta previa using a two-sample Mendelian randomization (MR) approach. Genome-wide association study (GWAS) data will be analyzed to assess the correlation and potential causality between VEGF protein levels and the occurrence of placenta previa.', 'detailedDescription': 'Placenta previa is a serious complication during pregnancy, leading to significant risks for both the mother and the fetus. This study utilizes Mendelian randomization (MR) to explore the potential causal link between plasma levels of VEGF family proteins (including VEGFA, VEGFB, VEGFC, VEGFD, and PLGF) and the risk of placenta previa. By using genome-wide association study (GWAS) data from the UK Biobank and FinnGen datasets, the study aims to provide insights into the role of angiogenesis and abnormal placental development. The MR analysis will help minimize confounding factors and provide robust evidence regarding the causal relationship between VEGF proteins and placenta previa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study analyzes data from European populations included in genome-wide association studies (GWAS) from UK Biobank and FinnGen, focusing on individuals with available plasma VEGF family protein levels and placenta previa data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants included in genome-wide association studies (GWAS) with available data on plasma VEGF family proteins and placenta previa.\n\nExclusion Criteria:\n\n* Participants with incomplete or missing data on plasma VEGF levels or placenta previa.'}, 'identificationModule': {'nctId': 'NCT06620068', 'acronym': 'VEGF PP', 'briefTitle': 'Causal Relationship Between Plasma VEGF Family Proteins and Placenta Previa: A Two-Sample Mendelian Randomization Study', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'Causal Association Between Plasma Vascular Endothelial Growth Factor Family Proteins and Placenta Previa: A Two-Sample Mendelian Randomization Study', 'orgStudyIdInfo': {'id': 'FSKY20240924'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhibin Xu', 'role': 'CONTACT', 'email': 'unignorable_xuzhibin@outlook.com', 'phone': '+8615816832640'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'collaborators': [{'name': "The Second People's Hospital of Foshan", 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Foshan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhibin Xu', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}