Chronic Myeloid LeukemiaLMCNCT02869256
Regional Central Database Recording of Chronic Myeloid Leukemia
An observational study of Chronic Myeloid Leukemia, run by Institut Bergonié at 6 sites in France.
Trial summary
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Practices evaluation
- How many people
- 400 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2014to Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with chronic myeloid leukemia diagnosis in chronic phase
Who may be able to join
- chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast
- male or female patient aged 18 years or more
- Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information
- Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié
Who cannot join
- none
Trial locations and contacts
6 sites in 1 country.
Gabriel etienne, MD contact
Simone Mathoulin-Pelissier, MD PhD contact
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Polyclinique Bordeaux Nord
Bordeaux, 33000
Olivier FITOUSSI
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
François Xavier Mahon, MD PhD
- Recruiting
Institut Bergonié
Bordeaux
Gabriel Etienne
- Recruiting
Centre Hospitalier Universitaire de Dax
Dax, 40100
François LIFERMANN
- Recruiting
Centre hospitalier Libourne
Libourne
Joël CECCALDI
- Recruiting
Centre Hospitalier Universitaire de Pau
Pau, 64000
Corinne Dagada
About this study
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.
Read the detailed description
Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .
Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Practices evaluation
- Keywords
- chronic myeloid leukemia, practices evaluation
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practices evaluationOther
Practices evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance of the management of patients with chronic myeloid leukemia compared to the guidelines
Measured: 10 years
Secondary outcomes (1)
overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869256
- Sponsor's protocol ID
- IB2014-LMC
- Acronym
- LMC
- Status last verified
- Nov 2017
- First submitted
- 9 Aug 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Central Database Recording of Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02869256
- Acronym / sponsor ID
- LMC / IB2014-LMC
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- chronic myeloid leukemia, practices evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- 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.
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.
Detailed description
Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .
Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic myeloid leukemia diagnosis in chronic phase
Key inclusion criteria (4 listed)
- chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast
- male or female patient aged 18 years or more
- Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information
- Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practices evaluationPractices evaluation | Other | – |
Primary outcome
compliance of the management of patients with chronic myeloid leukemia compared to the guidelines
Time frame: 10 years
1 secondary outcome
overall survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Gabriel etienne, MD contact
Simone Mathoulin-Pelissier, MD PhD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Institut Bergonié at 6 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 4 inclusion and 1 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Gabriel etienne, MD (G.Etienne@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance of the management of patients with chronic myeloid leukemia compared to the guidelines (time frame: 10 years). 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 21 Nov 2017.