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

NCT06559579 | Completed

• 1 other identifier: 29BRC21.0282 - GammaClinik
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with monoclonal gammopathy of indeterminate significance (MGUS) or malignant hematology (myeloma, plasmocytoma, Waldenström disease, chronic lymphoid leukemia, B lymphoma), diagnosed between 2012 and 2017 and associated with a monoclonal gammopathy and clinical impairment within the spectrum of clinically significant gammopathy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU de Brest

Brest, 29609, France

Location

CHIC de Quimper

Quimper, France

Location

MeSH Terms

Conditions

Paraproteinemias

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 19, 2024
• Study Start: October 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)