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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFPE Blocks | Samples obtained from patients with multiple myeloma extramedullary disease. The samples should be obtained in the extramedullary disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease. | Number of participants who meet both criteria:
Feasibility will be quantified by reporting the proportion of eligible participants among all patients screened for potential inclusion. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains). | Percentage of cases showing immunoreactivity for selected markers based on standard immunohistochemistry performed during diagnostic work-up. Marker expression is recorded as positive or negative according to predefined laboratory thresholds. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the distribution of anatomical sites of extramedullary disease with clinicopathological characteristics of included cases. | Categorization of EMD cases according to the anatomical origin of the archived tissue sample (e.g., soft tissue, liver, CNS, lymph node). Measurement is performed by reviewing sample metadata recorded at the time of diagnostic tissue processing. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients diagnosed with extramedullary myeloma (excluding plasmacytoma) for whom a representative FFPE block from a surgical specimen was obtained as part of routine clinical care within the past 10 years. Only cases with sufficient clinical, pathological, and follow-up data are included. All samples were collected outside the context of research activities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie BREVET, Pr ; MD. PhD. | Contact | 33628010948 | m.brevet@biwako.fr |
| Name | Affiliation | Role |
|---|---|---|
| Heba Rashed | MEDARKRO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIWAKO | Lyon 06 | 69006 | France |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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The study plans to collect formalin fixed embedded samples (FFPE) and to cut unstained histopathological slides for immpunohistochemistry techniques. No DNA extraction
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |