Myeloproliferative Neoplasms: an In-depth Case-control Study
MOSAICC
2 other identifiers
observational
234
1 country
3
Brief Summary
There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The investigators conducted a systematic review of the literature which identified several cohort and case-control studies that have investigated a wide range of potential medical, environmental and occupational risk factors. However, these studies have been limited by a wide variation in case definition and small sample sizes limiting the potential to detect modest risk differences between cases and controls. The research group propose an exploratory case-control study of 100 patients with classic MPNs and 200 controls to determine the optimal methods for roll out of this study to a multi-centred UK-based case-control study that will investigate the aetiology of MPN subtypes. The objectives of the study are to evaluate recruitment procedures, response rates and the development of a telephone administered questionnaire. The findings of this exploratory study will form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
January 8, 2024
CompletedJanuary 8, 2024
March 1, 2023
1.2 years
March 27, 2013
July 29, 2015
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Influence of Pre- and Post- Incentives on Participation Rates.
* Difference in participation rates in those receiving: * vs. not receiving a pen at initial contact. * vs. not receiving a trolley token at initial contact. * vs. not receiving a monetary incentive at initial contact. * a MOSAICC pen vs. a non-branded pen following second contact. * vs. not receiving a trolley token following second contact. * a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive) * 0/1 of these incentives vs. receiving 2/3 incentives following a second invite. * Difference in proportion of patients completing study elements comparing: * 0/1 vs 2/3 incentives. * those receiving pre vs post invitation incentives.
average 2 weeks
Study Arms (3)
Myeloproliferative neoplasm case
Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria. Exclusion Criteria * younger than 18 years old. * where the clinician/General Practitioner (GP) does not provide consent. * incapable of giving informed consent. * physically or cognitively incapable of completing the questionnaire. * too ill to participate. We will assess whether a pen (branded, non-branded or none), a £10 cheque and/or a charity branded trolley token will affect uptake rates in the study.
General Practice Control
GP controls will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender. The following patient groups will be excluded. Those: * younger than 18 years old. * where the clinician/GP does not provide consent. * incapable of giving informed consent. * physically or cognitively incapable of completing the questionnaire. * too ill to participate. We will assess whether a pen (branded, non-branded or none), a £10 cheque (at study completion) and/or a charity branded trolley token will affect uptake rates in the study.
Non-blood relative or family Control
Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older. We will assess whether a pen (branded, non-branded or none) and/or a £10 cheque (at study completion) will affect uptake rates in the study. Only a limited number of trolley tokens were available so not assessed in this group.
Interventions
Randomisation of branded pen, non-branded pen and no pen
Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Trolley tokens to be randomly assigned to half of cases and General Practice controls.
Eligibility Criteria
Hematology clinic Primary Care clinic Non-blood relatives/ friends of cases
You may qualify if:
- Clinical diagnosis of polycythemia vera, essential thrombocythaemia or primary myelofibrosis based on the WHO diagnostic criteria.
- Aged 18 years or older.
You may not qualify if:
- younger than 18 years old.
- where the clinician/General Practitioner (GP) does not provide consent.
- incapable of giving informed consent.
- physically or cognitively incapable of completing the questionnaire.
- too ill to participate
- General Practice Controls
- Randomly selected, frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.
- Aged 18 years or older.
- younger than 18 years old.
- where the clinician/GP does not provide consent.
- incapable of giving informed consent.
- physically or cognitively incapable of completing the questionnaire.
- too ill to participate.
- Relative/Friend Controls
- Non-blood relative/friend of a case participating in the study.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- University Hospital Southampton NHS Foundation Trustcollaborator
- University of Manchestercollaborator
- Western Australian Institute for Medical Researchcollaborator
- Mayo Cliniccollaborator
Study Sites (3)
University Hospitals Southampton NHS Foundation Trust
Southampton, England, SO16 6YD, United Kingdom
Belfast Health And Social Care Trust
Belfast, Northern Ireland, BT12 6BJ, United Kingdom
Queen's University Belfast
Belfast, Northern Ireland, BT389EX, United Kingdom
Related Publications (3)
Anderson LA, Duncombe AS, Hughes M, Mills ME, Wilson JC, McMullin MF. Environmental, lifestyle, and familial/ethnic factors associated with myeloproliferative neoplasms. Am J Hematol. 2012 Feb;87(2):175-82. doi: 10.1002/ajh.22212. Epub 2011 Nov 11.
PMID: 22076943BACKGROUNDJames G, McMullin MF, Duncombe AS, Clarke M, Anderson LA. The MOSAICC study: Assessing feasibility for biological sample collection in epidemiology studies and comparison of DNA yields from saliva and whole blood samples. Ann Hum Genet. 2018 Mar;82(2):114-118. doi: 10.1111/ahg.12227. Epub 2017 Oct 27.
PMID: 29076129BACKGROUNDAnderson LA, James G, Duncombe AS, Mesa R, Scherber R, Dueck AC, de Vocht F, Clarke M, McMullin MF. Myeloproliferative neoplasm patient symptom burden and quality of life: evidence of significant impairment compared to controls. Am J Hematol. 2015 Oct;90(10):864-70. doi: 10.1002/ajh.24098. Epub 2015 Sep 10.
PMID: 26113113RESULT
Biospecimen
Venous blood sample (up to 12 ml) - whole blood, DNA Saliva (2ml) Dried Blood spots (500 µl) Toe-nails (2 great toe-nail clippings)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Lesley Anderson
- Organization
- Queen's University Belfast
Study Officials
- PRINCIPAL INVESTIGATOR
Lesley A Anderson, PhD
Queen's University, Belfast
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 15, 2013
Study Start
April 1, 2013
Primary Completion
July 1, 2014
Study Completion
June 1, 2015
Last Updated
January 8, 2024
Results First Posted
January 8, 2024
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data is available from 01/09/2018 and will be available for a period of 5 years in the first instance.
- Access Criteria
- * Non commercial * Contracts/legal team to review data transfer agreements * Data transfer and use policy document * Completion of a data access form (obtainable from Dr Anderson l.anderson@qub.ac.uk)
Researchers can contact the study lead (Dr Anderson) to request a data access form. Once a data access form has been completed it will be reviewed by the study team and a decision made. If sharing of data has been agreed by the study team the contracts department and legal teams will review the proposed sharing of data to ensure that it meets with international standards.