Multiple MyelomaNCT05995808
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
A study testing Bone marow biopsy and aspiration and biochemical and heamatological tests in people with Multiple Myeloma, run by Sohag University.
Trial summary
Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bone marow biopsy and aspiration and biochemical and heamatological tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients older than 18 year with newly diagnosed MM.
- Approval to sign an informed written consent.
Who cannot join
- 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.
Trial locations and contacts
No sites are listed yet.
Douaa M Sayed, professor contact
About this study
Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma .
There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).
- Conditions
- Multiple Myeloma
- Being tested
- Bone marow biopsy and aspiration, biochemical and heamatological tests
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marow biopsy and aspirationProcedure or surgery
Bone marrow biopsy and biopsy aspiration
biochemical and heamatological testsDiagnostic test
Also called complete blood count ,urea and creatinine in serum
complete blood count ,serum urea and creatinine
| Study group | Role | What they receive |
|---|---|---|
| diagnostic group | Experimental | Not described Receives: Procedure: Bone marow biopsy and aspiration; Diagnostic Test: biochemical and heamatological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fainan Khaled Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995808
- Sponsor's protocol ID
- Soh-Med-23-07-02MD
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
- ClinicalTrials.gov ID
- NCT05995808
- Acronym / sponsor ID
- Soh-Med-23-07-02MD
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Aug 2023 (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.
Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma .
There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic group | Experimental | Procedure: Bone marow biopsy and aspiration, Diagnostic Test: biochemical and heamatological tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 year with newly diagnosed MM.
- Approval to sign an informed written consent.
Key exclusion criteria (1 listed)
- 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.
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 |
|---|---|---|
| Bone marow biopsy and aspirationBone marrow biopsy and biopsy aspiration | Procedure or surgery | diagnostic group |
| biochemical and heamatological testsAlso: complete blood count ,urea and creatinine in serumcomplete blood count ,serum urea and creatinine | Diagnostic test | diagnostic group |
Primary outcome
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Time frame: 1 year
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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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.
Douaa M Sayed, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Bone marow biopsy and aspiration and biochemical and heamatological tests in people with Multiple Myeloma, 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 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 16 Aug 2023. 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 Fainan K EL Kady, spcialist (01063017967, fainan_khaled_post@med.sohag.edeu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient (time frame: 1 year). 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 16 Aug 2023.