CARTOGEN: Optical Genome Mapping in Hematological Malignancies

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05009537
Collaborator
(none)
200
4
60
50
0.8

Study Details

Study Description

Brief Summary

Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Optical Genome Mapping in Hematological Malignancies
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer [2021-2026]

      identification of anomalies by mapping identical to those identified by combining conventional cytogenetics and FISH.

    Secondary Outcome Measures

    1. identification of new chromosomal abnormalities of clinical relevance. [2021-2026]

    2. identification of new chromosomal anomalies involved in oncogenic pathways [2021-2026]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Minor/Major Patients

    • Patients with suspected hemopathies for whom we receive a sample for diagnosis in the chromosomal genetics laboratory or for whom a diagnosis of hemopathy has already been made.

    • No objection made or consent given

    Exclusion Criteria:
    • Patients under judicial protection (guardianship, curatorship, ...),

    • Refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609
    2 CH Morlaix, service d'hémato clinique Morlaix France
    3 CHIC, service d'hémato clinique Quimper France
    4 CH St Brieuc, service d'hémato clinique Saint-Brieuc France

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05009537
    Other Study ID Numbers:
    • CARTOGEN - 29BRC21.0211
    First Posted:
    Aug 17, 2021
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2021