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临床试验/NCT07354555
NCT07354555
尚未招募
不适用

Discovery And Validation Of New Biomarkers In The Context Of Multiple Myeloma Extramedulary Disease

BIWAKO1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年6月5日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
BIWAKO
入组人数
15
试验地点
1
主要终点
Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease.

概览

简要总结

This observational study aims to evaluate the feasibility of assembling a retrospective cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma, together with their associated clinical and pathological data. The study will determine whether these archived samples are suitable for exploratory biomarker assessment.

No intervention is performed. All FFPE samples and clinical data originate exclusively from routine diagnostic procedures and will be analyzed retrospectively for research purposes.

详细描述

This retrospective observational study aims to determine the feasibility of assembling a cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma and linking these materials with associated clinical and pathological data. All samples originate from routine diagnostic procedures performed as part of standard clinical care; no prospective interventions or additional tissue collection are involved.

The study evaluates whether archived FFPE specimens and corresponding clinical information can be systematically identified, retrieved, and abstracted using a predefined standardized workflow. Histopathological review and immunohistochemical markers routinely assessed during diagnostic work-up (CD138, CD56, MUM1, light chains) will be used to confirm the diagnosis and describe tumor features. Feasibility will be defined by the proportion of screened cases for which both adequate FFPE material and sufficient clinical data are available to allow inclusion.

The purpose of the study is to generate a structured dataset enabling future biomarker research and to assess whether the operational workflow used for case identification, data abstraction, and sample processing can be reliably scaled for larger retrospective cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with histologically confirmed extramedullary myeloma (excluding plasmacytoma).
  • Availability of a representative FFPE block from a surgical specimen.
  • Diagnosis established within the past 10 years.
  • Availability of associated clinical and follow-up data.

排除标准

  • Patients with plasmacytoma only.
  • Insufficient or non-representative FFPE material.
  • Missing key diagnostic or clinical data.

结局指标

主要结局

Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease.

时间窗: Baseline

Number of participants who meet both criteria: * confirmation of extramedullary disease using predefined clinical and histopathological criteria, and * availability of an adequate FFPE tissue block suitable for inclusion. Feasibility will be quantified by reporting the proportion of eligible participants among all patients screened for potential inclusion.

次要结局

  • Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).(Baseline)

研究者

发起方
BIWAKO
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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