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

NCT ID: NCT06559579

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-10-30

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.

Conditions

Gammopathy, Monoclonal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Brest

Brest, , France

CHIC de Quimper

Quimper, , France

Countries

France

Other Identifiers

29BRC21.0282 - GammaClinik

Identifier Type: -

Identifier Source: org_study_id