Chronic Lymphoid LeukaemiaOFICENCT03294980
Chronic Lymphoid Leukaemia Observatory in Finistere Area, France
An observational study of Chronic Lymphoid Leukaemia, run by University Hospital, Brest at 1 site in France.
Trial summary
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphoid Leukaemia
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2025
- 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 Lymphoid Leukaemia
Who may be able to join
- Age of at least 18 years
- Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
- Willing and able to provide informed consent
- Willing and able to provide blood sample at time of enrollment
Who cannot join
- Diagnosis of other B-cell malignancies
Trial locations and contacts
1 site in 1 country.
Yves Renaudineau contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Yves Renaudineau, Yves.renaudineau@chu-brest.fr
Adrian Tempescul, adrian.tempescul@chu-brest.fr
About this study
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.
Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.
- Conditions
- Chronic Lymphoid Leukaemia
- Keywords
- Chronic lymphocytic leukemia, Observational study
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Clinical data
Measured: Year 0 (Y)
Secondary outcomes (2)
Incidence
Clinical and biological data
Measured: Year 0
Description of baseline clinical-biological
Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected
Measured: Year 0, Year 1, Year 2, Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startNov 2015
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphoid LeukaemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Reanudineau, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294980
- Sponsor's protocol ID
- OFICE
- Acronym
- OFICE
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2016
- Last updated
- 28 Jan 2021
- Results posted
- No
Publications
Marlin A, Le Pape F, Troadec T, Le Goff J, Tripier R, Berthou C, Patinec V. Zn2+ triazamacrocyclic chelators with methylpyridine pendant arms for B-cell apoptosis: a structure-activity study. Dalton Trans. 2025 Feb 25;54(9):3939-3951. doi: 10.1039/d4dt02962c.
PubMed 39895421Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.
PubMed 31014395Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.
PubMed 30696487
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Lymphoid Leukaemia Observatory in Finistere Area, France
- ClinicalTrials.gov ID
- NCT03294980
- Acronym / sponsor ID
- OFICE / OFICE
- Conditions
- Chronic Lymphoid Leukaemia
- Keywords
- Chronic lymphocytic leukemia, Observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 27 Sep 2017 (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.
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.
Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.
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 Lymphoid Leukaemia
Key inclusion criteria (4 listed)
- Age of at least 18 years
- Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
- Willing and able to provide informed consent
- Willing and able to provide blood sample at time of enrollment
Key exclusion criteria (1 listed)
- Diagnosis of other B-cell malignancies
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
Prevalence
Time frame: Year 0 (Y)
Clinical data
2 secondary outcomes
Incidence
Time frame: Year 0
Description of baseline clinical-biological
Time frame: Year 0, Year 1, Year 2, Year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 39895421Marlin A, Le Pape F, Troadec T, Le Goff J, Tripier R, Berthou C, Patinec V. Zn2+ triazamacrocyclic chelators with methylpyridine pendant arms for B-cell apoptosis: a structure-activity study. Dalton Trans. 2025 Feb 25;54(9):3939-3951. doi: 10.1039/d4dt02962c.
- Derived from this study: PubMed 31014395Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.
- Derived from this study: PubMed 30696487Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.
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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.
Yves Renaudineau contact
Yves Reanudineau study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphoid Leukaemia, run by University Hospital, Brest at 1 site 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yves Renaudineau (yves.renaudineau@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: Year 0 (Y)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294980, which also lists 3 linked publications.
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 28 Jan 2021.