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| ID | Type | Description | Link |
|---|---|---|---|
| 193751 | Other Identifier | IRAS (Integrated Research Application System) | |
| 16/EE/0071 | Other Identifier | East of England - Cambridge South Research Ethics Committee |
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| Name | Class |
|---|---|
| RxCelerate Limited | UNKNOWN |
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This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
Monoclonal gammopathy of unknown significance (MGUS) is a common haematological condition. It is characterised by proliferation of a B lymphocyte clone and it's associated antibody (paraprotein). In most cases there are no clinical symptoms, however, in a small number of individuals there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen). This can have effects on the normal function of this molecule and/or cause disease.
The study aims to investigate the functional consequences of paraprotein production in MGUS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Nurse visit for blood sample, questionnaire and phone call |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample taken | Other |
| ||
| Answering a lifestyle questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges. | For clinical assays with defined normal ranges, we will capture those results that are significantly outside of normal range. For those with no generally accepted normal ranges, the results will be compared against results from the other individuals. | Up to 4 years from study start |
| Measure | Description | Time Frame |
|---|---|---|
| The number of conversions to multiple myeloma | 2 years after the first visit |
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Inclusion Criteria:
Participants must comply with the following criteria in order to be eligible for the study:
Exclusion Criteria:
Participants will be excluded from joining the study if they match any of the criteria below:
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The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.
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| Name | Affiliation | Role |
|---|---|---|
| Jill Reckless | RxCelerate Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Berkshire Hospital | Reading | Berkshire | United Kingdom | |||
| Addenbrookes Hospital |
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Plasma and serum
| Other |
|
| Follow-up phone call from researcher (two years after first visit) | Other | To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma. |
|
| Cambridge |
| Cambridgeshire |
| CB2 0QQ |
| United Kingdom |
| Torbay Hospital | Torquay | Devon | United Kingdom |
| Heartlands Hospital | Birmingham | West Midlands | United Kingdom |
| St James's Hospital | Leeds | West Yorkshire | United Kingdom |
| Guy's and St. Thomas' Hospital | London | SE1 9RT | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital | Nottingham | United Kingdom |
| Rotherham Hospital | Rotherham | S602UD | United Kingdom |
| ID | Term |
|---|---|
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| ID | Term |
|---|---|
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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