Nctid:
NCT06614595
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011289", "term"=>"Preleukemia"}, {"id"=>"D000009190", "term"=>"Myelodysplastic Syndromes"}], "ancestors"=>[{"id"=>"D000001855", "term"=>"Bone Marrow Diseases"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000011230", "term"=>"Precancerous Conditions"}, {"id"=>"D000009369", "term"=>"Neoplasms"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M14164", "name"=>"Preleukemia", "asFound"=>"Myelodysplastic Syndrome", "relevance"=>"HIGH"}, {"id"=>"M12145", "name"=>"Myelodysplastic Syndromes", "asFound"=>"Myelodysplastic Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M14111", "name"=>"Precancerous Conditions", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "asFound"=>"Quality of Life", "relevance"=>"HIGH"}, {"id"=>"T3993", "name"=>"Myelodysplastic Syndromes", "asFound"=>"Myelodysplastic Syndrome", "relevance"=>"HIGH"}, {"id"=>"T6036", "name"=>"Menopause", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"serum and plasma for cytokine analysis"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Troponin and NTproBNP as predictors for QoL improvement", "timeFrame"=>"Troponin and NTproBNP will be analyzed the day of transfusion and seven days after", "description"=>"To evaluate the utility of serum pretransfusional troponine and NTPROBNP as cardiac biomarkers to identify those patients whose QoL improves after the rbc transfusion"}, {"measure"=>"Cardiorespiratory function", "timeFrame"=>"Ergospirometry will be performed at the inclusion in the study", "description"=>"To evaluate the utility of oxygen consumption measured by ergospirometry to evalaute cardiorespiratory function and as a predictor of QoL improvement after rbc transfusion"}, {"measure"=>"Cytokines", "timeFrame"=>"Cytokines will be analyzed before abc transfusion and seven days after it", "description"=>"To analyze changes in pro and anti-inflammatory cytokines before and after rbc transfusion"}], "primaryOutcomes"=>[{"measure"=>"Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale", "timeFrame"=>"We expect to obtain results in one year from the beginning of the study", "description"=>"To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement"}], "secondaryOutcomes"=>[{"measure"=>"Changes in QoL before and after transfusion", "timeFrame"=>"QoL will be asses the day of transfusion and seven days after", "description"=>"QoL will be assessed with QUALMS instrument, The QUALMS is being supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team. He will collaborate and assist in the interpretation of the HRQoL results."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Myelodysplastic Syndromes", "Red blood cell transfusion", "Quality of life"], "conditions"=>["Low Risk Myelodysplastic Syndromes"]}, "referencesModule"=>{"references"=>[{"pmid"=>"26944474", "type"=>"BACKGROUND", "citation"=>"Abel GA, Efficace F, Buckstein RJ, Tinsley S, Jurcic JG, Martins Y, Steensma DP, Watts CD, Raza A, Lee SJ, List AF, Klaassen RJ. Prospective international validation of the Quality of Life in Myelodysplasia Scale (QUALMS). Haematologica. 2016 Jun;101(6):781-8. doi: 10.3324/haematol.2015.140335. Epub 2016 Mar 4."}, {"pmid"=>"34251040", "type"=>"BACKGROUND", "citation"=>"Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12."}]}, "descriptionModule"=>{"briefSummary"=>"Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent.\n\nChanges in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.", "detailedDescription"=>"At inclusion and before red blood cell (rbc) transfusion, patients cardiorespiratory function will be evaluated with an ergospirometer\n\nLikewise, before and after rbc transfusion, patients will be asked to complete the QUALMS, a QoL instrument which will be supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team.\n\nBefore and after rbc transfusion, hemoglobin, pretrasfusional hemoglobin, pre and post cardiac biomarkers troponin and NTproBNP will be collect.Pre and post serum and plasma will also be collected for cytokine analysis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Subjects must meet all of the following inclusion criteria:\n\n1. They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.\n2. Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.\n3. Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.\n4. Very low, low or intermediate IPSS-R risk category.\n5. Subject requires are red blood cell transfusion dependent with the following criteria: requires an average of 2 to 6 units of CH on average over an 8-week period.\n6. ECOG 0-3.\n\nExclusion criteria\n\n1. Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.\n2. High or very high IPSS-R risk category.\n3. Subject diagnosed with any active neoplasm except:\n\n * epidermoid or basal cell carcinoma,\n * carcinoma in situ of the uterine cervix\n * Carcinoma in situ of the breast\n4. Subjects with a score on the New York Heart Association Scale IV.\n5. Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.\n6. Subject with known clinically significant anaemia due to iron, vitamin B12 or folate deficiencies or autoimmune or hereditary haemolytic anaemia or uncontrolled hypothyroidism or known clinically significant haemorrhage or sequestration or subject with drug induced anaemia.\n7. New onset or uncontrolled seizures.\n8. Subjects with uncontrolled systemic fungal, bacterial or viral infections (defined as ongoing signs or symptoms related to the infection without improvement despite appropriate antibiotics or antimicrobial therapy).\n9. Pregnant or breastfeeding women.\n10. The subject has any condition, including the presence of laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in the study.\n11. The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data."}, "identificationModule"=>{"nctId"=>"NCT06614595", "acronym"=>"MDS-QUAL", "briefTitle"=>"Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS", "organization"=>{"class"=>"OTHER", "fullName"=>"Fundación para la Investigación Biosanitaria del Principado de Asturias"}, "officialTitle"=>"Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life Changes", "orgStudyIdInfo"=>{"id"=>"2024.244"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33011", "city"=>"Oviedo", "state"=>"Asturias", "status"=>"RECRUITING", "country"=>"Spain", "contacts"=>[{"role"=>"CONTACT", "email"=>"bernaldelcastillo@gmail.com", "phone"=>"985108000", "phoneExt"=>"37613"}, {"name"=>"Teresa Bernal del CastilloBernal del Castillo", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Hospital Universitario Central de Asturias", "geoPoint"=>{"lat"=>43.36029, "lon"=>-5.84476}}], "centralContacts"=>[{"name"=>"Teresa Bernal del Castillo", "role"=>"CONTACT", "email"=>"bernaldelcastillo@gmail.com", "phone"=>"985108000", "phoneExt"=>"37613"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fundación para la Investigación Biosanitaria del Principado de Asturias", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Hospital Universitario Central de Asturias", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator, MD, PHD", "investigatorFullName"=>"Teresa Bernal del Castillo", "investigatorAffiliation"=>"Fundación para la Investigación Biosanitaria del Principado de Asturias"}}}}