NCT05009537

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2021Sep 2026

First Submitted

Initial submission to the registry

August 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 16, 2021

Last Update Submit

August 16, 2021

Conditions

MDSALLOther Hematologic Malignant Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • identification of new chromosomal abnormalities of clinical relevance.

    2021-2026

  • identification of new chromosomal anomalies involved in oncogenic pathways

    2021-2026

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected hemopathies

You may qualify if:

  • 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

You may not qualify if:

  • Patients under judicial protection (guardianship, curatorship, ...),
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU de Brest

Brest, 29609, France

RECRUITING

CH Morlaix, service d'hémato clinique

Morlaix, France

RECRUITING

CHIC, service d'hémato clinique

Quimper, France

RECRUITING

CH St Brieuc, service d'hémato clinique

Saint-Brieuc, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fresh cells from bone marrow frozen cells frmp bone marrow

Central Study Contacts

Marie-Bérengère, TROADEC, PhD

CONTACT

(33)230338055Marie-berengere.troadec@chu-brest.fr

Nathalie DOUET-GUILBERT, MD, PhD

CONTACT

(33)230338055nathalie.douet-guilbert@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 17, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion (Estimated)

September 1, 2026

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
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

Locations

FR(4)