Multiple Myeloma, NeoplasmsNCT06667583
5p15/ 9q22/ 15q22 Hyperdiploidy and Their Significance in Multiple Myeloma Patients
An observational study of Multiple Myeloma, Neoplasms, run by Assiut University.
Trial summary
Our study aims to detect 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma, Neoplasms
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2026
- 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: Newly diagnosed Multiple Myeloma Patients
Who may be able to join
- Newly diagnosed Multiple Myeloma Patients -
Who cannot join
- Patient of Multiple Myeloma who received treatment
- -
Trial locations and contacts
No sites are listed yet.
About this study
Our study aims to detect 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
Read the detailed description
Multiple myeloma is a malignancy of terminally differentiated B cells(immunoglobulin-producing long lived plasma cells ).Its a Bone Marrow based,multifocal plasma cell neoplasm,Multiple myeloma (MM) is the second most common hematologic malignancy.It is mostly observed in older adults with a median age of 66 to 70 years .The exact etiology of multiple myeloma is unknown. However, frequent alterationsand translocations in the promoter genes, especially chromosome 14, are commonly found in multiple myeloma and likely play a role in disease development.In addition, other oncogenes such as NRAS, KRAS, and BRAF may participate in plasma cell proliferation In the majority of patients,malignant proliferation of plasma cells causes the M protein (abnormal IgG, IgM, or IgA or rarely IgE or IgD) in serum and/or urine. Typical symptoms are hypercalcemia, renal failure, anaemia, or destructive bone lesions ("CRAB") The definition of HD in MM has varied across studies; one study defined HD as numerous chromosomal trisomies and low prevalence of IgH translocations and another as a chromosome count of 48-65, with a gain of at least two odd chromosome, Multiple myeloma can be distinguished into two major subgroups based on the genetic abnormalities that all patients harbor; hyperdiploid MM (≥47 and <75 chromosomes; H-MM) and non-hyperdiploid MM (NH-MM).1 NH-MM is further divided into three subgroups: hypodiploid (≤44 chromosomes), pseudodiploid (45-46 chromosomes) and near tetraploid (>75 chromosomes), H-MM has been defined by multiple chromosomal gains, preferentially of the odd chromosomes 3, 5, 7, 9, 11, 15, 19 and 21.Hyperdiploidy is usually associated with a favourable prognosis.
cytogenetic mutations in MM divided into two classes: primary and secondary. primary mutations that occur during the monoclonal gammopathy of undetermined significance (MGUS) stage, a noncancerous condition that affects plasma cells.The primary mutations typically affect the immunoglobulin genes,the most common trusted Source primary mutation is hyperdiploidy,which causes three chromosomes to develop instead of two, it can be observed in around half of the patients and is considered as a favorable prognostic factor, Secondary mutations occur later in the disease or during its progression.Secondary mutations can also be monosomic, where the mutation causes one member of a chromosome pair to be missing
- Conditions
- Multiple Myeloma, Neoplasms
- Keywords
- Hyperdiploidy
- Medical subject headings
- Multiple Myeloma, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
Measured: up to 2 yeqrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, NeoplasmsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Gamal Abd El-Nasser, Assiut University
- Investigators
- dalia abd el naser, resident dr, Principal investigator, Assiut UniversityEman Zaki, Professor, Study director, Assiut Universitysafia hussein, Lecturer, Study director, Assiut Universitymohammed El nagar, Ass profesor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667583
- Sponsor's protocol ID
- Hyperdiploidy in MM Patients
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5p15/ 9q22/ 15q22 Hyperdiploidy and Their Significance in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT06667583
- Acronym / sponsor ID
- Hyperdiploidy in MM Patients
- Conditions
- Multiple Myeloma, Neoplasms
- Keywords
- Hyperdiploidy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 31 Oct 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.
Our study aims to detect 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
Detailed description
Multiple myeloma is a malignancy of terminally differentiated B cells(immunoglobulin-producing long lived plasma cells ).Its a Bone Marrow based,multifocal plasma cell neoplasm,Multiple myeloma (MM) is the second most common hematologic malignancy.It is mostly observed in older adults with a median age of 66 to 70 years .The exact etiology of multiple myeloma is unknown. However, frequent alterationsand translocations in the promoter genes, especially chromosome 14, are commonly found in multiple myeloma and likely play a role in disease development.In addition, other oncogenes such as NRAS, KRAS, and BRAF may participate in plasma cell proliferation In the majority of patients,malignant proliferation of plasma cells causes the M protein (abnormal IgG, IgM, or IgA or rarely IgE or IgD) in serum and/or urine. Typical symptoms are hypercalcemia, renal failure, anaemia, or destructive bone lesions ("CRAB") The definition of HD in MM has varied across studies; one study defined HD as numerous chromosomal trisomies and low prevalence of IgH translocations and another as a chromosome count of 48-65, with a gain of at least two odd chromosome, Multiple myeloma can be distinguished into two major subgroups based on the genetic abnormalities that all patients harbor; hyperdiploid MM (≥47 and <75 chromosomes; H-MM) and non-hyperdiploid MM (NH-MM).1 NH-MM is further divided into three subgroups: hypodiploid (≤44 chromosomes), pseudodiploid (45-46 chromosomes) and near tetraploid (>75 chromosomes), H-MM has been defined by multiple chromosomal gains, preferentially of the odd chromosomes 3, 5, 7, 9, 11, 15, 19 and 21.Hyperdiploidy is usually associated with a favourable prognosis.
cytogenetic mutations in MM divided into two classes: primary and secondary. primary mutations that occur during the monoclonal gammopathy of undetermined significance (MGUS) stage, a noncancerous condition that affects plasma cells.The primary mutations typically affect the immunoglobulin genes,the most common trusted Source primary mutation is hyperdiploidy,which causes three chromosomes to develop instead of two, it can be observed in around half of the patients and is considered as a favorable prognostic factor, Secondary mutations occur later in the disease or during its progression.Secondary mutations can also be monosomic, where the mutation causes one member of a chromosome pair to be missing
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed Multiple Myeloma Patients
Key inclusion criteria (1 listed)
- Newly diagnosed Multiple Myeloma Patients -
Key exclusion criteria (2 listed)
- Patient of Multiple Myeloma who received treatment
- -
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
detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
Time frame: up to 2 yeqrs
detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Ravi, G. and Gonsalves, W.I. (2021) Current Diagnosis, Risk Stratification and Treatment Paradigms in Newly Diagnosed Multiple Myeloma. Cancer Treatment and Research Communications, 29, Article ID: 100444Link provided by the sponsor.
- Nassar, S., Taher, A., Spear, R., Wang, F., Madewell, J.E. and Mujtaba, B. (2021) Multiple Myeloma: Role of Imaging in Diagnosis, Staging, and Treatment Response Assessment. Seminars in Ultrasound, CT and MRI, 42, 184-193.Link provided by the sponsor.
- Cowan, A.J., Green, D.J., Kwok, M., Lee, S., Coffey, D.G., Holmberg, L.A., Tuazon, S., Gopal, A.K. and Libby, E.N. (2022) Diagnosis and Management of Multiple Myeloma: A Review. JAMA, 327, 464-477Link provided by the sponsor.
- Abdallah, N., et al. (2020). Cytogenetic abnormalities in multiple myeloma: association with disease characteristics and treatment response.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
dalia abd el naser, resident dr principal investigator
Assiut University
Eman Zaki, Professor study director
Assiut University
safia hussein, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, Neoplasms, 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 2 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 Nov 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 Dalia Abd el naser, resident dr (01016321671, Dalia.16266095@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients (time frame: up to 2 yeqrs). 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 Nov 2024.