Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-04 @ 8:57 AM
Study NCT ID:
NCT02067832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'From recipient: whole blood From donor: bone marrow or apheresis product'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-02-17', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients', 'timeFrame': 'Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months', 'description': 'The study will try to determine the prevalence (or levels) of high-probability predictive plasma and cellular cGVHD bio-markers in pediatric patients undergoing allogeneic HSCT from blood samples'}], 'secondaryOutcomes': [{'measure': 'Validation of "predictive" cGVHD bio-markers', 'timeFrame': 'Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)', 'description': 'To determine and validate whether "predictive" cGVHD bio-markers present before the onset of cGVHD are able to predict a subset of pediatric patients at greatest risk for the development of cGVHD in the future'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Graft vs Host Disease']}, 'referencesModule': {'references': [{'pmid': '36219586', 'type': 'DERIVED', 'citation': 'Cuvelier GDE, Ng B, Abdossamadi S, Nemecek ER, Melton A, Kitko CL, Lewis VA, Schechter T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Chaudhury S, Coulter D, Chewning JH, Joyce M, Savasan S, Pawlowska AB, Megason GC, Mitchell D, Cheerva AC, Lawitschka A, Ostroumov E, Schultz KR. A diagnostic classifier for pediatric chronic graft-versus-host disease: results of the ABLE/PBMTC 1202 study. Blood Adv. 2023 Jul 25;7(14):3612-3623. doi: 10.1182/bloodadvances.2022007715.'}, {'pmid': '34534280', 'type': 'DERIVED', 'citation': 'Subburaj D, Ng B, Kariminia A, Abdossamadi S, Lauener M, Nemecek ER, Rozmus J, Kharbanda S, Kitko CL, Lewis VA, Schechter-Finklestein T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Coulter D, Chewning JH, Joyce M, Pawlowska AB, Megason GC, Lawitschka A, Ostroumov E, Klein Geltink R, Cuvelier GDE, Schultz KR. Metabolomic identification of alpha-ketoglutaric acid elevation in pediatric chronic graft-versus-host disease. Blood. 2022 Jan 13;139(2):287-299. doi: 10.1182/blood.2021013244.'}]}, 'descriptionModule': {'briefSummary': 'Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients.\n\nThe research will look into identifying and validating cGVHD biological indicators (=bio-markers) which will be evaluated whether they can predict a future development of the disease.\n\nThe study hypothesis is that a number of previously reported cGVHD bio-markers, known to be present at the time of cGVHD diagnosis, will also be present at earlier time points, before cGVHD develops.\n\nFollowing validation, the bio-markers will be beneficial for finding those patients who are in higher risk to develop cGVHD.\n\nBy identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive therapy might be applied in order to prevent or reduce the prevalence of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recipients and donors of allogeneic hematopoietic stem cell transplantation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.\n2. Age 0-17.99 years at the time of transplantation.\n3. Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.\n4. Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.\n5. Use of serotherapy is permitted.\n6. Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.\n7. If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.\n8. If participant weighs over 20 kg, participant must be able to provide 1ml/kg of whole blood, up to a maximum of 23 mL for the pre-conditioning sample and 32 mL for samples at day +100, 6-months, 12-months, +/- the cGVHD sample.\n9. Written informed consent from parents.\n10. Assent from study participant when appropriate.\n11. Participation on other clinical trials is acceptable.\n\nExclusion Criteria:\n\n1. Autologous HSCT.\n2. Patients referred to a Bone Marrow Transplant (BMT) center from a non-BMT center, where it is anticipated (at the discretion of the center PI) that adequate follow up according to the rules of this protocol can not be met, including the requirement for a reassessment by the BMT center at the time of cGVHD diagnosis.\n3. Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).\n4. Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).\n5. Syngeneic transplants.'}, 'identificationModule': {'nctId': 'NCT02067832', 'acronym': 'ABLE-cGVHD', 'briefTitle': 'Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease', 'orgStudyIdInfo': {'id': 'H12-02890'}, 'secondaryIdInfos': [{'id': 'TCF-118695', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institutes of Health Research'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours A. I. DuPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60611-2605', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48109-1274', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital The University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Blair E. Batson Hospital for Children', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68198-7140', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Utah Primary Children's Medical Center", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Vienna', 'country': 'Austria', 'facility': "ST.Anna Children's Hospital", 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "University of British Columbia - BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3T 2N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'The Sainte-Justine University Hospital Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Geoff Cuvelier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Kirk R Schultz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Kirk Schultz', 'investigatorAffiliation': 'University of British Columbia'}}}}