Nctid:
NCT06232668
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011225", "term"=>"Pre-Eclampsia"}], "ancestors"=>[{"id"=>"D000046110", "term"=>"Hypertension, Pregnancy-Induced"}, {"id"=>"D000011248", "term"=>"Pregnancy Complications"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M14106", "name"=>"Pre-Eclampsia", "asFound"=>"Preeclampsia", "relevance"=>"HIGH"}, {"id"=>"M7633", "name"=>"Eclampsia", "relevance"=>"LOW"}, {"id"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M25635", "name"=>"Hypertension, Pregnancy-Induced", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"T2019", "name"=>"Eclampsia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Chorionic villi biopsy and maternal peripheral blood samples with circulating genetic material (C-RNA/C-DNA) and other biomolecules and cellular component to provide preeclampsia information and other obstetric complications."}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>2084}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2026-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To charactise the molecular profile of the maternal-fetal interface between 9 and 14 weeks of gestation in healthy and preeclamptic pregnancies", "timeFrame"=>"18 months", "description"=>"Differentially expressed genes between control vs preeclampsia group at the level of cell types/subtypes"}], "secondaryOutcomes"=>[{"measure"=>"To characterise the molecular profile of the maternal-fetal interface between 9 and 14 weeks of gestation in pregnancies diagnosed with pregnancy complication other than preeclampsia", "timeFrame"=>"18 months", "description"=>"Differentially expressed genes between control vs cases group at the level of cell types/subtypes."}, {"measure"=>"To characterise the epigenome and metabolome of individual cells from the maternal-fetal interface in healthy pregnancies and those diagnosed with preeclampsia or other pregnancy complication", "timeFrame"=>"24 months", "description"=>"Differentially methylation profiles and differentially metabolites between control vs cases group at the level of cell types/subtypes."}, {"measure"=>"The discovery and validation of molecular markers as candidates for early diagnosis and/or therapy", "timeFrame"=>"30 months", "description"=>"Area Under the ROC Curve and/or cell type phenotyping in in vitro cultures after disrupting the candidate"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Preeclampsia", "Early onset Preeclampsia (EOPE)", "First trimester", "Chorionic villi", "Pregnancy", "Molecular study", "Decidua", "Maternal-fetal interface", "Other pregnancy complications", "Omic techniques"], "conditions"=>["Preeclampsia"]}, "descriptionModule"=>{"briefSummary"=>"Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in chorionic villi collected during gestational weeks 9 to 14. Chorionic villi will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.", "detailedDescription"=>"The hypothesis is that those women who develop PE have impaired decidualization associated with shallow cytotrophoblast invasion during the development of the maternal-fetal interface whose molecular profile analysis at the single cell level will allow characterization of PE development prior to the onset of symptoms.\n\nThe purposed study is a biomedical, prospective, multicentre, case-control aimed to characterize the molecular profile of the maternal-foetal interface in the first trimester of pregnancy early in the development of preeclampsia using single-cell sequencing technology. Distinguishing the maternal and fetal origin of the chorionic biopsy cells , describing the maternal-foetal interface and deciphering the intercellular communications and altered pathways in PE and other obstetric complications could be suggested as a secondary outcome, as well as the characterization of the blood sample, the epigenome and metabolome of single cells or the validation of markers of the different cell types.\n\nSubjects will be 2084 pregnant women over the age of 18 recruited between 9 and 14 gestational weeks. Patients attending the participating referral centers for a chorionic villus biopsy due to the detection of a foetal chromosomal abnormality risk will provide the leftover chorionic biopsy sample after determination of the risk of trisomies and a peripheral blood sample for genotyping of maternal lymphocytes and circulating cRNA.\n\nData will be registered in an electronic Case Report Form (eCRF) specifically designed for this study. Monitoring activities and data verification will be performed during the whole study to ensure data quality, integrity and transparency.\n\nThe total estimated duration of the study is 36 months, of which the first 24 months will correspond to the recruitment period of the participants."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Pregnant women over the age of 18 recruited between 9 and 14 gestational weeks who attend the participating referral centers for a chorionic villus biopsy due to the detection of a foetal chromosomal abnormality risk.", "genderDescription"=>"Pregnant women over 18 years old", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.\n* Women over the age of 18 at the time of signing the informed consent form.\n* Pregnant women with a single gestation between weeks 9 and 14 of gestation who will undergo a chorionic villus biopsy according to the centre's usual clinical practice.\n\nExclusion Criteria:\n\n* Women with multiple pregnancy.\n* Non-evolving pregnancies (including delayed abortion/foetal orbit)."}, "identificationModule"=>{"nctId"=>"NCT06232668", "acronym"=>"PREMAFE", "briefTitle"=>"Molecular Study of the Maternal-fetal Interface in Preeclampsia.", "organization"=>{"class"=>"OTHER", "fullName"=>"Carlos Simon Foundation"}, "officialTitle"=>"Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.", "orgStudyIdInfo"=>{"id"=>"FCS-IMF-TG-23-03"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Cases group", "description"=>"Women recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy.", "interventionNames"=>["Procedure: Chorionic biopsy and peripheral blood collection in cases group"]}, {"label"=>"Control group", "description"=>"Women recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy", "interventionNames"=>["Procedure: Chorionic biopsy and peripheral blood collection in control group"]}], "interventions"=>[{"name"=>"Chorionic biopsy and peripheral blood collection in cases group", "type"=>"PROCEDURE", "description"=>"Chorionic villi will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in cases group. Clinical data will be compiled.", "armGroupLabels"=>["Cases group"]}, {"name"=>"Chorionic biopsy and peripheral blood collection in control group", "type"=>"PROCEDURE", "description"=>"Chorionic villi will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in control group. Clinical data will be compiled.", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Murcia", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Juan Luis Delgado", "role"=>"CONTACT", "email"=>"juanluisdelgado@tokos.org", "phone"=>"+34 968 36 96 74"}], "facility"=>"Hospital Clinico Universitario Virgen de la Arrixaca", "geoPoint"=>{"lat"=>37.98704, "lon"=>-1.13004}}, {"city"=>"Valencia", "status"=>"RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Rogelio Monfort Ortiz", "role"=>"CONTACT", "email"=>"monfort_isaort@gva.es", "phone"=>"+34 961 24 40 00"}, {"name"=>"Beatriz Marcos Puig", "role"=>"CONTACT", "email"=>"marcos_bea@gva.es", "phone"=>"+34 961 24 40 00"}], "facility"=>"Hospital Universitario y Politécnico La Fe", "geoPoint"=>{"lat"=>39.46975, "lon"=>-0.37739}}], "centralContacts"=>[{"name"=>"Carla Gómez, BSc, MSc", "role"=>"CONTACT", "email"=>"cgomez@fundacioncarlossimon.com", "phone"=>"+34962938210"}, {"name"=>"Carlos Simón, MD, PhD", "role"=>"CONTACT"}], "overallOfficials"=>[{"name"=>"Tamara Garrido, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Fundación Carlos Simon para la investigación en salud de la mujer"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Carlos Simon Foundation", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
