Chronic Lymphocytic LeukemiaNCT01346020
Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation. 1. Read more about this study
- Who is it for?
- Ages 0 to 130 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to 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 0 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic lymphocytic leukemia
Who may be able to join
- diagnosis of CLL,
- at least two available stored samples
Who cannot join
- at least one inclusion criterium not fulfilled
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of human genetics, University Hospital Leuven
Leuven, 3000
About this study
This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation.
- Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized.
- Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians.
- Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.
- Conditions
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CLL | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to therapy
Time from diagnosis to the start of first line therapy
Measured: baseline to day 1 of therapy
Secondary outcomes (1)
Genetic abnormalities detected by karyotyping, FISH or array-analysis
Detection of any type of genetic abnormality or pattern of abnormalities present at diagnosis or at time of disease progression (e.g. median 41 months after diagnosis, range 13-102 months) by means of karyotyping, fluorescent in situ hybridization or array-analysis.
Measured: 13-102 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2010
- 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.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346020
- Sponsor's protocol ID
- S53270
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2011
- Last updated
- 1 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01346020
- Acronym / sponsor ID
- S53270
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 May 2011 (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.
This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation.
- Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized.
- Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians.
- Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLL | – | – |
Who may qualify
- Ages
- 0 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic lymphocytic leukemia
Key inclusion criteria (2 listed)
- diagnosis of CLL,
- at least two available stored samples
Key exclusion criteria (1 listed)
- at least one inclusion criterium not fulfilled
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
Time to therapy
Time frame: baseline to day 1 of therapy
Time from diagnosis to the start of first line therapy
1 secondary outcome
Genetic abnormalities detected by karyotyping, FISH or array-analysis
Time frame: 13-102 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lymphocytic Leukemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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 1 Jul 2024. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to therapy (time frame: baseline to day 1 of therapy). 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 1 Jul 2024.