Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02339805
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the clonal evolution during and after treatment by Next Generation Sequencing', 'timeFrame': 'one year', 'description': 'DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'One year', 'description': 'time between inclusion and progression or relapse or beginning of a new treatment'}, {'measure': 'Overall survival', 'timeFrame': 'one year', 'description': 'time between inclusion and death'}, {'measure': 'Assess the clonal architecture in tumor DNA and bone marrow', 'timeFrame': 'one year'}, {'measure': 'Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Minimal residual disease, NGS, NHL, DNA sequencing'], 'conditions': ['Non Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '26883583', 'type': 'DERIVED', 'citation': 'Camus V, Sarafan-Vasseur N, Bohers E, Dubois S, Mareschal S, Bertrand P, Viailly PJ, Ruminy P, Maingonnat C, Lemasle E, Stamatoullas A, Picquenot JM, Cornic M, Beaussire L, Bastard C, Frebourg T, Tilly H, Jardin F. Digital PCR for quantification of recurrent and potentially actionable somatic mutations in circulating free DNA from patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2016 Sep;57(9):2171-9. doi: 10.3109/10428194.2016.1139703. Epub 2016 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment', 'detailedDescription': 'To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age up to 18 years old\n* With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma\n* Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like\n* First line of treatment\n* Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration)\n* Written informed consent\n* Tumor biopsy used for diagnosis available\n\nExclusion Criteria:\n\n* Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like\n* Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)\n* Pregnant or breast-feeding woman\n* Guardianship, curatorship\n* Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons'}, 'identificationModule': {'nctId': 'NCT02339805', 'acronym': 'LymphoSeq', 'briefTitle': 'Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)', 'orgStudyIdInfo': {'id': 'CHB13.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'next generation sequencing', 'description': 'Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.', 'interventionNames': ['Other: next generation sequencing', 'Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)']}], 'interventions': [{'name': 'next generation sequencing', 'type': 'OTHER', 'description': 'DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.', 'armGroupLabels': ['next generation sequencing']}, {'name': 'Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)', 'type': 'DEVICE', 'description': 'tumor Assessment tool during the study', 'armGroupLabels': ['next generation sequencing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Fabrice Jardin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Henri Becquerel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'collaborators': [{'name': 'U918 ( Inserm unit)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}