Optical Genome Mapping in Hematological Malignancies (CARTOGEN)

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

Study Overview

• Status: Recruiting
• Conditions: MDS; ALL; Other Hematologic Malignant Neoplasms

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Marie-Bérengère, TROADEC, PhD; Phone Number: (33)230338055; Email: Marie-berengere.troadec@chu-brest.fr
• Study Contact Backup: Name: Nathalie DOUET-GUILBERT, MD, PhD; Phone Number: (33)230338055; Email: nathalie.douet-guilbert@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Marie-Bérengère, TROADEC; Email: Marie-berengere.troadec@chu-brest.fr
  • Morlaix, France
    • Recruiting
    • CH Morlaix, service d'hémato clinique
    • Contact: Christophe NICOL, MD
  • Quimper, France
    • Recruiting
    • CHIC, service d'hémato clinique
    • Contact: Léanig LE CLEACH, MD
  • Saint-Brieuc, France
    • Recruiting
    • CH St Brieuc, service d'hémato clinique
    • Contact: Cédric DUCLOS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected hemopathies

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer	identification of anomalies by mapping identical to those identified by combining conventional cytogenetics and FISH.	2021-2026

Secondary Outcome Measures

Outcome Measure	Time Frame
identification of new chromosomal abnormalities of clinical relevance.	2021-2026
identification of new chromosomal anomalies involved in oncogenic pathways	2021-2026

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: CARTOGEN - 29BRC21.0211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No