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临床试验/NCT07823959
NCT07823959尚未招募不适用

Association of CBC-Based Inflammatory Indices With Clinical, Laboratory, and Immunophenotypic Characteristics of Newly Diagnosed Multiple Myeloma

Assiut University0 个研究点目标入组 60 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Bone Marrow Plasma Cell Percentage

研究概览

简要总结

Multiple myeloma is a type of blood cancer characterized by the abnormal growth of plasma cells in the bone marrow. Increasing evidence indicates that interactions between myeloma cells and the host immune-inflammatory response influence disease behavior and patient outcomes. Inflammatory markers calculated from routine complete blood count (CBC) tests, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR), offer simple, inexpensive ways to assess systemic inflammation. However, how these markers correlate with baseline clinical presentation, laboratory disease burden, and tumor cell immunophenotypes remains insufficiently explored.

The primary purpose of this cross-sectional study is to evaluate the association between CBC-based inflammatory indices and clinical and laboratory measures of disease severity in patients with newly diagnosed multiple myeloma prior to the start of anti-myeloma therapy. The study will also examine the relationship between these inflammatory indices and the specific immunophenotypic characteristics of neoplastic plasma cells identified via bone marrow flow cytometry.

A total of 60 patients with newly diagnosed multiple myeloma presenting to Assiut University Hospital and the South Egypt Cancer Institute will be enrolled. Baseline demographic and clinical data (including CRAB manifestations and ISS/R-ISS staging), routine blood laboratory results (including albumin, beta-2 microglobulin, and LDH), bone marrow plasma cell percentages, and flow cytometric findings will be collected and analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Newly diagnosed Multiple Myeloma patients, evaluated prior to the initiation of anti-myeloma therapy
  • Both sexes, with no age restriction

排除标准

  • Prior receipt of anti-myeloma treatment
  • Concurrent active malignancies or other hematological disorders
  • Presence of acute or chronic inflammatory or infectious conditions that may influence systemic inflammatory indices
  • Concomitant use of medications that significantly alter inflammatory or hematological parameters

研究组 & 干预措施

Newly Diagnosed Multiple Myeloma Patients

Patients with newly diagnosed Multiple Myeloma evaluated prior to the initiation of anti-myeloma therapy. Baseline evaluation includes clinical assessment (demographics, CRAB features, and ISS/R-ISS staging), routine laboratory testing (serum albumin, beta-2 microglobulin, LDH, serum calcium, and renal function tests), complete blood count (CBC) to calculate inflammatory indices (NLR, LMR, PLR, SII, SIRI, PIV, HALP, and CAR), and bone marrow examination (morphological plasma cell percentage and multiparametric flow cytometry for immunophenotypic profiling of neoplastic plasma cells).

结局指标

主要结局

Bone Marrow Plasma Cell Percentage

时间窗: Baseline

The percentage of clonal plasma cells quantified on bone marrow aspirate/biopsy smears at diagnosis. This parameter serves as the primary objective measure of tumor burden and disease severity to evaluate its relationship with baseline complete blood count (CBC)-derived inflammatory indices (specifically the neutrophil-to-lymphocyte ratio \[NLR\]).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mennatullah Sayed Sayed Abdelrazek

Resident of Clinical Pathology

Assiut University

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