MOSAICC: Myeloproliferative Neoplasms: an In-depth Case-control Study

Sponsor

Queen's University, Belfast (Other)

Overall Status

Unknown status

CT.gov ID

NCT01831635

Collaborator

University Hospital Southampton NHS Foundation Trust (Other), University of Manchester (Other), Western Australian Institute for Medical Research (Other), Mayo Clinic (Other)

300

Enrollment

Locations

Duration (Months)

100

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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, the development of a telephone administered questionnaire, compare occupational exposure assessment using OccIDEAS, a novel web based program, with a job-exposure matrix (FINJEM), evaluate the feasibility of collection of DNA from saliva compared to blood samples, identify potential aetiologic factors associated with MPNs and explore assessment of quality of life. 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.

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera Essential Thrombocythemia Primary Myelofibrosis	Other: Methodological pens Other: Methodological compensation Other: Methodological trolley tokens

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Myeloproliferative Neoplasms: an In-depth Case-control Study

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Methodological pens Randomisation of branded pen, non-branded pen and no pen Other: Methodological compensation Randomisation of a £10 monetary reimbursement for expenses on completion of the study Other: Methodological trolley tokens Trolley tokens to be randomly assigned to half of cases and General Practice controls.
General Practice Control For each MPN case one GP control 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. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic >50% in bed but not bedbound".	Other: Methodological pens Randomisation of branded pen, non-branded pen and no pen Other: Methodological compensation Randomisation of a £10 monetary reimbursement for expenses on completion of the study Other: Methodological trolley tokens Trolley tokens to be randomly assigned to half of cases and General Practice controls.
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.	Other: Methodological pens Randomisation of branded pen, non-branded pen and no pen Other: Methodological compensation Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Arm

Intervention/Treatment

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.

Other: Methodological pens

Randomisation of branded pen, non-branded pen and no pen

Other: Methodological compensation

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Other: Methodological trolley tokens

Trolley tokens to be randomly assigned to half of cases and General Practice controls.

General Practice Control

For each MPN case one GP control 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. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic >50% in bed but not bedbound".

Other: Methodological pens

Randomisation of branded pen, non-branded pen and no pen

Other: Methodological compensation

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Other: Methodological trolley tokens

Trolley tokens to be randomly assigned to half of cases and General Practice controls.

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.

Other: Methodological pens

Randomisation of branded pen, non-branded pen and no pen

Other: Methodological compensation

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Outcome Measures

Primary Outcome Measures

Influence of pre- and post- incentives on participation rates. [average 2 weeks]
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 & money following a second invite. 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.

Secondary Outcome Measures

Residence [Baseline]
Subjects will be asked to provide information on their residences of 6 months or longer duration starting at birth until current residence, along with postcode/area and proximity to potential environmental exposures such as power stations, power grids, golf courses, phone masts.
Occupational history using FINJEM [Baseline]
Subjects will complete a calendar of lifetime occupations lasting 6 months or longer including job title, year start- year end, job specific tasks and company (where applicable)
Occupational history using OccIDEAS [Baseline]
The 5 main occupations likely to have exposures of interest and based on duration will be examined in more detail asking specific questions to determine risk of exposures.
Medical history [Baseline]
Exposure to a range of medical conditions potentially associated with risk of myeloproliferative neoplasms.
Demographics [Baseline]
Information collected on childhood factors including education and other personal information such as marital status.
Tobacco use [Baseline]
Cigarette use
Alcohol [Baseline]
usual consumption of alcohol
Gardening and household exposures [Baseline]
cleaning product and gardening product use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Myeloproliferative neoplasm cases

Inclusion criteria:

Clinical diagnosis of polycythemia vera, essential thrombocythaemia or primary myelofibrosis based on the WHO diagnostic criteria.
Aged 18 years or older.

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

General Practice Controls

Inclusion Criteria:

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.

Exclusion Criteria:

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

Inclusion Criteria:

Non-blood relative/friend of a case participating in the study.
Aged 18 years or older.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Southampton NHS Foundation Trust	Southampton	England	United Kingdom	SO16 6YD
2	Belfast Health And Social Care Trust	Belfast	Northern Ireland	United Kingdom	BT12 6BJ
3	Queen's University Belfast	Belfast	Northern Ireland	United Kingdom	BT389EX