- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07823959
CBC-Based Inflammatory Indices in Newly Diagnosed Multiple Myeloma
Association of CBC-Based Inflammatory Indices With Clinical, Laboratory, and Immunophenotypic Characteristics of Newly Diagnosed Multiple Myeloma
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Newly diagnosed Multiple Myeloma patients, evaluated prior to the initiation of anti-myeloma therapy
- Both sexes, with no age restriction
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Bone Marrow Plasma Cell Percentage
Lasso di tempo: Baseline
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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]).
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Baseline
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Collaboratori e investigatori
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Malattie emiche e linfatiche
- Mieloma multiplo
Altri numeri di identificazione dello studio
- CBC Inflammatory Indices in MM
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .