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

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.

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Key information

Conditions

Gammopathy, Monoclonal Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Paraproteinemias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest, Brest, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Time frame: 5 years

The presence of a difference in the distribution of gammopathy-related clinical disorders between GMSI and hemopathies

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: GammaClinik

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Aug 19, 2024
Registry last updated: Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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