Clinical trial NCT06667583: 5p15/ 9q22/ 15q22 Hyperdiploidy and Their Significance in Multiple Myeloma Patients
Official title: 5p15/ 9q22/ 15q22 Hyperdiploidy and Their Significance in Multiple Myeloma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma, Neoplasms
Keywords: Hyperdiploidy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed Multiple Myeloma Patients

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

Newly diagnosed Multiple Myeloma Patients -

Exclusion Criteria:

Patient of Multiple Myeloma who received treatment

-

Primary outcomes:
measure: detection of 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients
timeFrame: up to 2 yeqrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: dalia abd el naser, resident dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Eman Zaki, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: safia hussein, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mohammed El nagar, Ass profesor
role: STUDY_DIRECTOR
References: