N/A
Completed N=234
Myeloproliferative Neoplasms: an In-depth Case-control Study
Polycythemia Vera · Essential Thrombocythemia · Myelofibrosis
Source: ClinicalTrials.gov NCT01831635 ↗
Enrolled (actual)
234
Serious AEs
—
Results posted
Jan 2024
Primary outcomePrimary: Influence of Pre- and Post- Incentives on Participation Rates. — 4; 6; 15; 69 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Influence of Pre- and Post- Incentives on Participation Rates. |
4; 6; 15; 69; 28; 54 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01831635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.