Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT03656835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response', 'timeFrame': 'Up to 2 years', 'description': 'The association of the expression measured by immuno-tethered lipoplex nanoparticle (ILN) biochip and quantitative reverse transcription polymerase chain reaction (qRT-PCR) will be displayed by scatter plot. Receiver operating characteristic (ROC) curves and corresponding area under the curves (AUCs) will be calculated and compared. With these data collected serially over time, patterns will be explored graphically using trace plots showing the trend across treatment for each individual participant.'}, {'measure': 'Early detection of relapse', 'timeFrame': 'Up to 2 years', 'description': 'Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B-Cell Lymphoma', 'Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type', 'Diffuse Large B-Cell Lymphoma, Not Otherwise Specified', 'High Grade B-Cell Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well nanochip technology (immuno-tethered lipoplex nanoparticle \\[ILN\\] biochip) works in monitoring treatment response and in detecting relapse in participants with diffuse large B-cell lymphoma. Finding genetic markers for diffuse large B-cell lymphoma may help identify participants with this disease and help predict the outcome of treatment. It is not yet known how well ILN biochip-based testing monitors treatment response or detects relapse in participants with diffuse large B-cell lymphoma.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Determine whether ILN biochip can be used to detect molecular marker(s) to monitor treatment response in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).\n\nII. Determine whether ILN biochip can promote early detection of disease relapse in patients with DLBCL.\n\nOUTLINE:\n\nParticipants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed treatment naive DLBCL. Subtypes including high grade B-cell lymphoma, not otherwise specified (NOS) and de-novo DLBCL including germinal center B-cell type (GCB) and non-GCB subtypes.\n* Intent to receive entire care (treatment and follow-up) at Ohio State University (OSU).\n* Receiving treatment with curative intent.\n* Receiving planned 6 cycles of chemotherapy.\n* Ability to consent.\n\nExclusion Criteria:\n\n* Transformed lymphomas.\n* DLBCL with leukemic presentation.\n* Primary central nervous system (CNS) lymphoma.\n* Participating in other clinical trial/ receiving experimental therapy.\n* Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation.\n* Pregnancy (positive serum or urine pregnancy test) or breast feeding.'}, 'identificationModule': {'nctId': 'NCT03656835', 'briefTitle': 'Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Pilot Study of Nanochip Technology for Monitoring Treatment Response and Detection of Relapse in Patients With Diffuse Large B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'OSU-18154'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01536', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (ILN biochip testing)', 'description': "Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.", 'interventionNames': ['Procedure: Molecular Nanotechnology']}], 'interventions': [{'name': 'Molecular Nanotechnology', 'type': 'PROCEDURE', 'otherNames': ['MNT'], 'description': 'Undergo ILN biochip testing', 'armGroupLabels': ['Diagnostic (ILN biochip testing)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Beth Christian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Beth Christian', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}