- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07785505
Musculoskeletal Ultrasound in Patients With Hematologic Malignancies
Musculoskeletal Ultrasonographic Findings in Patients With Hematologic Malignancies: A Diagnostic Imaging Study Protocol
This study evaluates the role and diagnostic value of musculoskeletal ultrasonography (MSUS) in adult patients with hematologic malignancies who present with musculoskeletal symptoms.
Hematologic malignancies (such as leukemia, lymphoma, and multiple myeloma) frequently involve the musculoskeletal system through bone marrow infiltration, bone destruction, or soft-tissue lesions. Musculoskeletal ultrasound is a non-invasive, radiation-free, and high-resolution imaging technique that allows real-time evaluation of joints, muscles, tendons, bursae, and superficial bone changes.
In this study, adult participants with confirmed blood cancers presenting with symptoms such as localized bone pain, joint swelling, muscle pain, or soft-tissue swelling will undergo a dedicated ultrasound examination of symptomatic areas. The study aims to characterize the patterns of musculoskeletal involvement (including cortical breaks, periosteal changes, soft-tissue masses, synovitis, and vascularity on Doppler imaging) and determine how these findings correlate with disease type, clinical presentation, and laboratory parameters.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Adult patients (aged 18 years or older) with a confirmed diagnosis of hematologic malignancy (leukemia, lymphoma, or multiple myeloma) established by bone marrow examination, histopathology, and/or immunophenotyping.
- Patients presenting with musculoskeletal symptoms and undergoing musculoskeletal ultrasonography for the assessment of musculoskeletal involvement at diagnosis or during follow-up.
- Patients willing and able to provide written informed consent.
Exclusion Criteria:
- Patients with a prior or concurrent solid organ malignancy with known skeletal metastasis.
- Patients with a history of major musculoskeletal trauma, orthopedic surgery, or active musculoskeletal infection affecting the examined region.
- Patients with other connective tissue diseases (e.g., systemic lupus erythematosus, systemic sclerosis).
- Patients with other inflammatory arthropathies (e.g., psoriatic arthritis, ankylosing spondylitis, reactive arthritis).
- Patients with incomplete clinical, laboratory, or follow-up data.
- Patients who decline to participate or withdraw consent.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Patients with Hematologic Malignancies
Adult patients (aged 18 years or older) with a confirmed diagnosis of hematologic malignancy (leukemia, lymphoma, or multiple myeloma) who present with musculoskeletal symptoms (e.g., bone pain, joint pain/swelling, muscle pain, soft-tissue swelling, limitation of movement, or functional impairment) and undergo diagnostic musculoskeletal ultrasonography (MSK-US) with grayscale B-mode and color/power Doppler imaging to evaluate musculoskeletal involvement.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percentage of Participants with Abnormal Musculoskeletal Ultrasonographic Findings
Tidsram: Baseline
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The percentage of participants exhibiting at least one abnormal sonographic finding on B-mode and color/power Doppler musculoskeletal ultrasound in symptomatic regions.
Abnormal findings include cortical breaks/erosions, periosteal elevation/subperiosteal collections, focal soft-tissue or intramuscular masses/infiltrative lesions, joint effusion, synovial thickening/hypertrophy, tenosynovitis, or increased Doppler flow vascularity.
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Baseline
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Neoplasmer efter plats
- Neoplasmer
- Ledsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Leukemi, myeloid
- Neoplasmer, Plasmacell
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Hemorragiska störningar
- Sarkom
- Neoplasmer, bindväv och mjukvävnad
- Hemiska och lymfsjukdomar
- Leukemi
- Hematologiska neoplasmer
- Lymfom
- Multipelt myelom
- Muskuloskeletala sjukdomar
- Sarkom, Myeloid
- Synovit
Andra studie-ID-nummer
- MSK Ultrasound in Blood Cancer
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