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

August 14, 2024 updated by: University Hospital, Brest

Comparative Study of Clinical Disorders Related to Monoclonal Gammopathy in Patients With Haematological Malignancies in Two Hospitals 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU de Brest
      • Quimper, France
        • CHIC de Quimper

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC21.0282 - GammaClinik

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning one year and ending five years following the publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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