Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:42 PM
Study NCT ID:
NCT07313592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bone marrow aspirate specimen and/or 1 mL of peripheral blood collection will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of success of ChromoSeq®', 'timeFrame': 'Time of specimen collection to completion of results (total estimated time is 15 days)', 'description': 'ChromoSeq® will be successful if the results on the first attempt in a real-time, clinical setting identifies recurrent structural variants and copy number alterations of conventional cytogenetics and karyotype. The success rate and the 95% confidence interval will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Comparison of time-to-results of ChromoSeq® and conventional cytogenetics', 'timeFrame': 'Time of specimen collection to 15 days after collection (total estimated time is 15 days)', 'description': 'The proportion of results return within 15 days and the 95% confidence interval will be calculated.'}, {'measure': 'Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients.', 'timeFrame': 'Time of specimen collection to completion of LDA testing (total estimated time is 15 days)', 'description': 'The outcome will be measured by determining the correlation of LDA testing on patients with neutral cytogenetics versus LDA testing on patients whose ChromoSeq® results display a Ph-like translocation for validation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'B-ALL', 'T-ALL', 'Next generation sequencing', 'Pediatric'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective specimen collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young adult acute lymphoid leukemia (ALL) patients. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup, and the patients will then be followed for clinical outcomes for up to 65 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Child and young adult patients diagnosed with acute lymphoid leukemia (ALL) seen at St. Louis Children's Hospital/Washington University School of Medicine.", 'healthyVolunteers': False, 'eligibilityCriteria': "Eligibility Criteria\n\n* Children and young adult patients (\\< 30 years of age at time of study enrollment) treated at St. Louis Children's Hospital/Washington University School of Medicine.\n* Suspected diagnosis or suspected relapse of acute lymphoblastic leukemia (ALL), B- or T-cell.\n* Concurrent enrollment on a prospective therapeutic trial is allowed as this protocol makes no recommendations regarding treatment approach.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document."}, 'identificationModule': {'nctId': 'NCT07313592', 'briefTitle': 'Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients', 'orgStudyIdInfo': {'id': '202512057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Child and Young Adult acute lymphoid leukemia (ALL) patients', 'description': 'At time of initial workup, patients will undergo bone marrow and/or peripheral blood collection for ChromoSeq® (requires 1 mL of peripheral blood or bone marrow aspirate).', 'interventionNames': ['Device: ChromoSeq® assay testing']}], 'interventions': [{'name': 'ChromoSeq® assay testing', 'type': 'DEVICE', 'description': 'Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.', 'armGroupLabels': ['Child and Young Adult acute lymphoid leukemia (ALL) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Margaret Ferris, MD, PhD', 'role': 'CONTACT', 'email': 'youngm@wustl.edu', 'phone': '314-454-6018'}, {'name': 'Margaret Ferris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Feng Gao, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Washington University School of Medicine/St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Margaret Ferris, MD, PhD', 'role': 'CONTACT', 'email': 'youngm@wustl.edu', 'phone': '314-454-6018'}], 'overallOfficials': [{'name': 'Margaret Ferris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after de-identification.', 'accessCriteria': 'Data will be uploaded to dbGaP.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'McDonnell Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}