PruritusPRURIGAMMANCT03832140
Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy
An observational study of Pruritus and Monoclonal Gammopathy, run by University Hospital, Brest at 1 site in France.
Trial summary
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Monoclonal Gammopathy
- How many people
- 281 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2019to 19 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had serum protein electrophoresis at Brest CHRU between 2014 and 2017, with and without gammapathy.
Who may be able to join
- Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated
- Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated
Who cannot join
- Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe
Trial locations and contacts
1 site in 1 country.
About this study
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.
Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls
- Conditions
- Pruritus, Monoclonal Gammopathy
- Medical subject headings
- Pruritus, Paraproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with monoclonal gammopathy | Not described | |
| patients with a normal plasma protein electrophoresis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pruritus
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start24 May 2019
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832140
- Sponsor's protocol ID
- PRURIGAMMA (29BRC18.0192)
- Acronym
- PRURIGAMMA
- Status last verified
- Aug 2020
- First submitted
- 5 Feb 2019
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy
- ClinicalTrials.gov ID
- NCT03832140
- Acronym / sponsor ID
- PRURIGAMMA / PRURIGAMMA (29BRC18.0192)
- Conditions
- Pruritus, Monoclonal Gammopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.
Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with monoclonal gammopathy | – | – |
| patients with a normal plasma protein electrophoresis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had serum protein electrophoresis at Brest CHRU between 2014 and 2017, with and without gammapathy.
Key inclusion criteria (2 listed)
- Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated
- Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated
Key exclusion criteria (1 listed)
- Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of pruritus
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pruritus and Monoclonal Gammopathy, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pruritus (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.