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Monoclonal Gammopathy With Clinical Significance in Patients With and Without Haematological Malignancies in Finistère Between 2012 and 2017 (GammaClinik)

Comparative Study of Clinical Disorders Related to Monoclonal Gammopathy in Patients With Haematological Malignancies in Two Hospitals in Finistère Between 2012 and 2017 (GammaClinik)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06559579
Acronym
GammaClinik
Enrollment
80
Registered
2024-08-19
Start date
2021-10-01
Completion date
2023-10-30
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gammopathy, Monoclonal

Brief summary

Clinical symptoms associated with monoclonal gammapathy have been primarily studied in hematological malignancy and rarely in MGUS and hemopathy. Indeed, most studies focus on a specific type of clinical involvement that does not allow to understand the epidemiological distribution of clinical symptoms in this population. In addition, in most cases, studies of clinical impairment of monoclonal gammapathies focus on one symptom. This study could highlight disparities in the representation of clinical disorders associated with monoclonal gammapathies, depending on whether they are or not associated with a malignant hematology, and would provide a better overall picture of the distribution of these diseases. This study could potentially define prognosis values for certain clinical conditions that we would not find in the group of hematological malignancies. This study would also make it possible to investigate whether there are clinical disorders of monoclonal gammapathies associated with chronic lymphoma/lymphocytic leukemia. This would potentially guide future pathophysiological research. This bicentric study could, depending on the results, be supplemented later by a larger study.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

ge \> 18 years Patient with monoclonal gammapathy of undetermined significance with clinical involvement associated with gammapathy or a malignant hematology (myeloma, plasmocytoma, Waldenström's disease, chronic lymphocytic leukemia, B lymphoma) with a monoclonal peak responsible for clinical impairment, Diagnosis of either monoclonal peak, haematopathy or clinical involvement between 2012 and 2017 Obtaining the non opposition NB: Clinical Impairment: * Amylose AL * cryoglobulinemia * acquired inhibitor C1 deficiency * Acquired Willebrand disease; * bullous dermatosis * xanthomatosis and xanthogranulomatosis neccrobiotic * Cold agglutinin disease; * peripheral neuropathy (anti MAG neuropathy, anti ganglioside, CANOMAD) * hemolytic uremic syndrome and PTT * anomaly alternate route of complement * POEMS syndrome * Capillary leak and clarkson syndrome * TEMPI syndrome * neutrophilic dermatosis: sweet syndrome, sneddon and wilkinson corneal pustulosis, erythema elvatum diutinum, pyoderma gangrenosum * cutis laxa acquis * mucinopapulosis * Schnitzler * myopathy (Sporadic Late Onset Nemaline Myopathy) * idiopathic thrombocytopenic purpura * autoimmune hemolytic anemia * hyperparathyroidia * amyotrophic lateral sclerosis * myasthenia * Overload crystalline histiocytosis * Crystalline keratopathy * GOMMID (monoclonal immunoglobulin microtubular organized deposition glomerulonephritis) * immunotactoid glomerulopathy * fanconi syndrome * randall disease * PGNMID (Monoclonal immunoglobulin light-chain non-Organic glomerulonephritis) * Glomerular basal anti-membrane disease * Extramembranous glomerulonephritis * glomerulonephritis with C3 deposition

Exclusion criteria

* Clinical involvement due to another condition of the patient (diabetes, hypertension, etc.) Clinical involvement due to chemotherapy Clinical involvement due to a strong tumor mass (IgM cutaneous deposition in Waldenström, cylindrical myeloma nephropathy, hyperviscosity syndrome in Waldenström) Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Search for a difference in the distribution of the various clinical conditions associated with monoclonal peaks in gammapathies of undetermined significance compared with hematological malignancies.5 yearsThe presence of a difference in the distribution of gammopathy-related clinical disorders between GMSI and hemopathies

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026