- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Bone Marrow Plasma Cell Percentage
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies hématologiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Tumeurs, plasmocyte
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Troubles hémorragiques
- Maladies hémiques et lymphatiques
- Myélome multiple
Autres numéros d'identification d'étude
- CBC Inflammatory Indices in MM
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