CLL ProgressionNCT04811950
Prognostic Role of Platelet _lymphocyte and Neutrophil _monocyte in CLL
An observational study of CLL Progression, run by Assiut University.
Trial summary
The biological rationale in calculating PLR stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advances stages of CLL .NMR median value was significantly higher in untreated patients than in patients who received treatment strengthening the hypothesis that this… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CLL Progression
- What is being tested?
- Emerald
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Oct 2023
- 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: All Patients with CLL come to South Egypt Cancer institute from 2010 to 2020
Who may be able to join
- All CLL patients
Who cannot join
- CLL patients on treatment
About this study
Official title: Assessment of Prognostic Role of Platelet-lymphocyte and Neutrophil _monocyte Ratio in CLL
The biological rationale in calculating PLR stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advances stages of CLL .NMR median value was significantly higher in untreated patients than in patients who received treatment strengthening the hypothesis that this ratio is associated with a more indolent form of disease
Read the detailed description
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in the western world. In Egypt, CLL is the most common subtype of leukemias
- the National Cancer Registry reported over 80% of lymphoid leukemias are CLL . It is the most common types of leukemia diagnosed in adult. ChroniclymphocyticleukemialymphocytesareclonalCD19-positiveBcells characterized by the accumulation of CD5 positive monoclonal B cells in peripheral blood. Bone marrow aspiration shows lymphocytic replacement of normal marrow elements, lymphocytes comprise 25-95% .Trephine biopsy reveals nodular, diffuse or interstitial involvement by lymphocytes
- Both the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and European Society of Medical Oncology guidelines also require persistence of lymphocytosis for longer than 3 months
The most important prognostic factors in CLL are clinical staging systems developed by Rai and Binet
. These systems based on clinical examination e.g. lymphadenopathy and organomegaly, peripheral blood findings (platelet andhaemoglobinvalues),markersoftumorload(thymidinekinaseand B2-microglobulin), expression of specific proteins in CLL cells; CD38, CD49d \& ZAP-70, genetic abnormalities quantified by FISH which include del(13q), tri12, del(11q), \& del(17p) and genetic parameters.including immunoglobulin heavy chain variable gene segment (IGHV) mutational status. Finally, prognostication in patients with CLL should not only address disease progression and overall survival, but also response to therapy. The biological rationale in calculating PLR stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advanced stages of CLL. Therefore, we hypothesized that the ratio using both the platelet and lymphocyte counts may have a prognostic role in patients with CLL. Neutrophil-monocyte ratio(NMR) was found to be higher in untreated patients than in patients who received treatment . and therefore it will be used to prove its relation with disease severity and itsprognosticvalues. It is important to highlight that using these indices, is simple, cheap, easily measured and reproducible and can be integrated into our daily clinical practice as prognostic marker of CLL
- Conditions
- CLL Progression
- Being tested
- Emerald
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmeraldDevice
Complete blood countdevice
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet-lymphocyte and neutrophilo_monocyte ratio in CLL
Calculating the ratio of platelets to lymphocytes and neutrophils to monocytes in CLL cases
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study startJun 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CLL ProgressionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Hussein Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811950
- Sponsor's protocol ID
- Prognostic factors in CLL
- Status last verified
- Mar 2021
- First submitted
- 30 Sep 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu H, Xu W, Shen QD. [Serum levels of soluble CD(23) and thrombopoietin in chronic lymphocytic leukemia]. Zhonghua Nei Ke Za Zhi. 2008 Oct;47(10):826-9. Chinese.
PubMed 19080142
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prognostic Role of Platelet-lymphocyte and Neutrophil _monocyte Ratio in CLL
- ClinicalTrials.gov ID
- NCT04811950
- Acronym / sponsor ID
- Prognostic factors in CLL
- Conditions
- CLL Progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Mar 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.
The biological rationale in calculating PLR stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advances stages of CLL .NMR median value was significantly higher in untreated patients than in patients who received treatment strengthening the hypothesis that this ratio is associated with a more indolent form of disease
Detailed description
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in the western world. In Egypt, CLL is the most common subtype of leukemias
- the National Cancer Registry reported over 80% of lymphoid leukemias are CLL . It is the most common types of leukemia diagnosed in adult. ChroniclymphocyticleukemialymphocytesareclonalCD19-positiveBcells characterized by the accumulation of CD5 positive monoclonal B cells in peripheral blood. Bone marrow aspiration shows lymphocytic replacement of normal marrow elements, lymphocytes comprise 25-95% .Trephine biopsy reveals nodular, diffuse or interstitial involvement by lymphocytes
- Both the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and European Society of Medical Oncology guidelines also require persistence of lymphocytosis for longer than 3 months
The most important prognostic factors in CLL are clinical staging systems developed by Rai and Binet
. These systems based on clinical examination e.g. lymphadenopathy and organomegaly, peripheral blood findings (platelet andhaemoglobinvalues),markersoftumorload(thymidinekinaseand B2-microglobulin), expression of specific proteins in CLL cells; CD38, CD49d \& ZAP-70, genetic abnormalities quantified by FISH which include del(13q), tri12, del(11q), \& del(17p) and genetic parameters.including immunoglobulin heavy chain variable gene segment (IGHV) mutational status. Finally, prognostication in patients with CLL should not only address disease progression and overall survival, but also response to therapy. The biological rationale in calculating PLR stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advanced stages of CLL. Therefore, we hypothesized that the ratio using both the platelet and lymphocyte counts may have a prognostic role in patients with CLL. Neutrophil-monocyte ratio(NMR) was found to be higher in untreated patients than in patients who received treatment . and therefore it will be used to prove its relation with disease severity and itsprognosticvalues. It is important to highlight that using these indices, is simple, cheap, easily measured and reproducible and can be integrated into our daily clinical practice as prognostic marker of CLL
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients with CLL come to South Egypt Cancer institute from 2010 to 2020
Key inclusion criteria (1 listed)
- All CLL patients
Key exclusion criteria (1 listed)
- CLL patients on treatment
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 |
|---|---|---|
| EmeraldComplete blood countdevice | Device | – |
Primary outcome
platelet-lymphocyte and neutrophilo_monocyte ratio in CLL
Time frame: base line
Calculating the ratio of platelets to lymphocytes and neutrophils to monocytes in CLL cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 19080142Yu H, Xu W, Shen QD. [Serum levels of soluble CD(23) and thrombopoietin in chronic lymphocytic leukemia]. Zhonghua Nei Ke Za Zhi. 2008 Oct;47(10):826-9. Chinese.
- Individual participant dataSharing planned: No
Related trials for CLL Progression
RecruitingPhase 3
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
CLL / SLL, CLL (Chronic Lymphocytic 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL Progression, run by Assiut University.
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 1 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
platelet-lymphocyte and neutrophilo_monocyte ratio in CLL (time frame: base line). 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 NCT04811950, which also lists 1 linked publication.
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 23 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.