Hematological MalignanciesNCT06258629
Prognostic Value of "CD200" in Hematological Malignancies. Hematological Malignancies Comprise a Group of Malignant Clonal Disorders Arising From the Hematopoietic Tissues , Including Leukemia , Multiple Myeloma , and They Have a High Morbidity and Mortality
An observational study of Hematological Malignancies, run by Sohag University.
Trial summary
Prognostic value of 'CD200' in hematological malignancies Hematological malignancies comprise a group of malignant clonal disorders arising from the hematopoietic tissues , including leukemia , multiple myeloma , and lymphoma , and they have a high morbidity and mortality Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Flowcytometry on bone marrow aspiration
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 6 Feb 2025
- How long will I take part?
- 6 Months
- 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 1 year to 60 years
- All sexes
- Child, Adult
Study population: * Control group of healthy individuals. * Newly diagnosed cases of hematological malignancis.
Who may be able to join
- Newly diagnosed cases of hematological malignancis.
Who cannot join
- Known cases of hematological malignancies and on treatment.
Trial locations and contacts
No sites are listed yet.
sherine Ph aziz, resident contact
About this study
Official title: Resident of Clinical Pathology in Sohag Oncology Center
Prognostic value of 'CD200' in hematological malignancies Hematological malignancies comprise a group of malignant clonal disorders arising from the hematopoietic tissues , including leukemia , multiple myeloma , and lymphoma , and they have a high morbidity and mortality
- Conditions
- Hematological Malignancies
- Being tested
- Flowcytometry on bone marrow aspiration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowcytometry on bone marrow aspirationDiagnostic test
Flowcytometry on bone marrow aspiration
| Study group | Role | What they receive |
|---|---|---|
| control group | Age and sex matched healthy control individuals Receives: Diagnostic Test: Flowcytometry on bone marrow aspiration | |
| Case group | Available number of patients with newly diagnosed as hematological malignancy Receives: Diagnostic Test: Flowcytometry on bone marrow aspiration | |
| Case group after 6 months | Available number of patients with newly diagnosed as hematological malignancy after 6 months of starting treatment. Receives: Diagnostic Test: Flowcytometry on bone marrow aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of CD200 diagnostic marker assessed by flow cytometry
Prognostic value of CD200 in hematological malignancies
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion6 Feb 2025 (estimated)
- Study completion6 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Yahia Hashim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258629
- Sponsor's protocol ID
- soh-med-24-01-03MS
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Biondi A, Cazzaniga G. Novel clinical trials for pediatric leukemias: lessons learned from genomic analyses. Hematology Am Soc Hematol Educ Program. 2013;2013:612-9. doi: 10.1182/asheducation-2013.1.612.
PubMed 24319240Carvajal LA, Neriah DB, Senecal A, Benard L, Thiruthuvanathan V, Yatsenko T, Narayanagari SR, Wheat JC, Todorova TI, Mitchell K, Kenworthy C, Guerlavais V, Annis DA, Bartholdy B, Will B, Anampa JD, Mantzaris I, Aivado M, Singer RH, Coleman RA, Verma A, Steidl U. Dual inhibition of MDMX and MDM2 as a therapeutic strategy in leukemia. Sci Transl Med. 2018 Apr 11;10(436):eaao3003. doi: 10.1126/scitranslmed.aao3003.
PubMed 29643228Chiaretti S, Vitale A, Cazzaniga G, Orlando SM, Silvestri D, Fazi P, Valsecchi MG, Elia L, Testi AM, Mancini F, Conter V, te Kronnie G, Ferrara F, Di Raimondo F, Tedeschi A, Fioritoni G, Fabbiano F, Meloni G, Specchia G, Pizzolo G, Mandelli F, Guarini A, Basso G, Biondi A, Foa R. Clinico-biological features of 5202 patients with acute lymphoblastic leukemia enrolled in the Italian AIEOP and GIMEMA protocols and stratified in age cohorts. Haematologica. 2013 Nov;98(11):1702-10. doi: 10.3324/haematol.2012.080432. Epub 2013 May 28.
PubMed 23716539Coles SJ, Wang EC, Man S, Hills RK, Burnett AK, Tonks A, Darley RL. CD200 expression suppresses natural killer cell function and directly inhibits patient anti-tumor response in acute myeloid leukemia. Leukemia. 2011 May;25(5):792-9. doi: 10.1038/leu.2011.1. Epub 2011 Jan 28.
PubMed 21274000
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident of Clinical Pathology in Sohag Oncology Center
- ClinicalTrials.gov ID
- NCT06258629
- Acronym / sponsor ID
- soh-med-24-01-03MS
- Conditions
- Hematological Malignancies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 6 Feb 2025 (estimated)
- Study completion
- 6 Feb 2025 (estimated)
- First posted
- 14 Feb 2024 (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.
Prognostic value of 'CD200' in hematological malignancies Hematological malignancies comprise a group of malignant clonal disorders arising from the hematopoietic tissues , including leukemia , multiple myeloma , and lymphoma , and they have a high morbidity and mortality
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: Flowcytometry on bone marrow aspirationAge and sex matched healthy control individuals |
| Case group | – | Diagnostic Test: Flowcytometry on bone marrow aspirationAvailable number of patients with newly diagnosed as hematological malignancy |
| Case group after 6 months | – | Diagnostic Test: Flowcytometry on bone marrow aspirationAvailable number of patients with newly diagnosed as hematological malignancy after 6 months of starting treatment. |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- * Control group of healthy individuals. * Newly diagnosed cases of hematological malignancis.
Key inclusion criteria (1 listed)
- Newly diagnosed cases of hematological malignancis.
Key exclusion criteria (1 listed)
- Known cases of hematological malignancies and 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 |
|---|---|---|
| Flowcytometry on bone marrow aspirationFlowcytometry on bone marrow aspiration | Diagnostic test | Case group, Case group after 6 months, control group |
Primary outcome
Level of CD200 diagnostic marker assessed by flow cytometry
Time frame: one year
Prognostic value of CD200 in hematological malignancies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 24319240Biondi A, Cazzaniga G. Novel clinical trials for pediatric leukemias: lessons learned from genomic analyses. Hematology Am Soc Hematol Educ Program. 2013;2013:612-9. doi: 10.1182/asheducation-2013.1.612.
- Background: PubMed 29643228Carvajal LA, Neriah DB, Senecal A, Benard L, Thiruthuvanathan V, Yatsenko T, Narayanagari SR, Wheat JC, Todorova TI, Mitchell K, Kenworthy C, Guerlavais V, Annis DA, Bartholdy B, Will B, Anampa JD, Mantzaris I, Aivado M, Singer RH, Coleman RA, Verma A, Steidl U. Dual inhibition of MDMX and MDM2 as a therapeutic strategy in leukemia. Sci Transl Med. 2018 Apr 11;10(436):eaao3003. doi: 10.1126/scitranslmed.aao3003.
- Background: PubMed 23716539Chiaretti S, Vitale A, Cazzaniga G, Orlando SM, Silvestri D, Fazi P, Valsecchi MG, Elia L, Testi AM, Mancini F, Conter V, te Kronnie G, Ferrara F, Di Raimondo F, Tedeschi A, Fioritoni G, Fabbiano F, Meloni G, Specchia G, Pizzolo G, Mandelli F, Guarini A, Basso G, Biondi A, Foa R. Clinico-biological features of 5202 patients with acute lymphoblastic leukemia enrolled in the Italian AIEOP and GIMEMA protocols and stratified in age cohorts. Haematologica. 2013 Nov;98(11):1702-10. doi: 10.3324/haematol.2012.080432. Epub 2013 May 28.
- Background: PubMed 21274000Coles SJ, Wang EC, Man S, Hills RK, Burnett AK, Tonks A, Darley RL. CD200 expression suppresses natural killer cell function and directly inhibits patient anti-tumor response in acute myeloid leukemia. Leukemia. 2011 May;25(5):792-9. doi: 10.1038/leu.2011.1. Epub 2011 Jan 28.
- Individual participant dataSharing planned: Undecided
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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.
sherine Ph aziz, resident contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies, run by Sohag 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 14 Feb 2024. 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?
Contact Reem ya Hashim, resident (01285481488, reem011091@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of CD200 diagnostic marker assessed by flow cytometry (time frame: one year). 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 NCT06258629, which also lists 4 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 14 Feb 2024.