MDSCARTOGENNCT05009537
Optical Genome Mapping in Hematological Malignancies
An observational study of MDS and ALL, run by University Hospital, Brest at 4 sites in France.
Trial summary
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MDS, ALL, Other Hematologic Malignant Neoplasms
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2021to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected hemopathies
Who may be able to join
- 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
Who cannot join
- Patients under judicial protection (guardianship, curatorship, ...),
- Refusal to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Marie-Bérengère, TROADEC, Marie-berengere.troadec@chu-brest.fr
- Recruiting
CH Morlaix, service d'hémato clinique
Morlaix
Christophe NICOL, MD
- Recruiting
CHIC, service d'hémato clinique
Quimper
Léanig LE CLEACH, MD
- Recruiting
CH St Brieuc, service d'hémato clinique
Saint-Brieuc
Cédric DUCLOS, MD
About this study
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer
- Conditions
- MDS, ALL, Other Hematologic Malignant Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021-2026
Secondary outcomes (2)
identification of new chromosomal abnormalities of clinical relevance.
Measured: 2021-2026
identification of new chromosomal anomalies involved in oncogenic pathways
Measured: 2021-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009537
- Sponsor's protocol ID
- CARTOGEN - 29BRC21.0211
- Acronym
- CARTOGEN
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Genome Mapping in Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05009537
- Acronym / sponsor ID
- CARTOGEN / CARTOGEN - 29BRC21.0211
- Conditions
- MDS, ALL, Other Hematologic Malignant Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected hemopathies
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under judicial protection (guardianship, curatorship, ...),
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer
Time frame: 2021-2026
identification of anomalies by mapping identical to those identified by combining conventional cytogenetics and FISH.
2 secondary outcomes
identification of new chromosomal abnormalities of clinical relevance.
Time frame: 2021-2026
identification of new chromosomal anomalies involved in oncogenic pathways
Time frame: 2021-2026
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDS and ALL, run by University Hospital, Brest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Bérengère, TROADEC, PhD ((33)230338055, Marie-berengere.troadec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer (time frame: 2021-2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.