INVESTIGATING SECULAR TRENDS IN THE SURVIVAL OF MELANOMA PATIENTS IN ENGLAND

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33317
• EU PAS number:
  EUPAS30299
• Study ID:
  33317
• Official title and acronym:
  INVESTIGATING SECULAR TRENDS IN THE SURVIVAL OF MELANOMA PATIENTS IN ENGLAND
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is an observational cohort study of patients diagnosed with malignant melanoma using cancer registration data from Pubic Health England (PHE). Our study aims to provide a detailed evaluation of melanoma survival over time in England. As previous studies have shown that melanoma survival varies significantly according to patient demographic characteristics, and particularly socioeconomic status we will also evaluate whether any observed changes over time vary within different subgroups, specifically disease stage and SES. Patients aged 18 years and above who are diagnosed with malignant melanoma of any stage from 1 January 1985 to 31 December 2015 will be identified from English Cancer Registry data held by Public Health England (PHE). The study period will span from 1 January 1985 until the latest available data (currently projected to be 31 December 2016). We will use the existing cancer registration data from PHE. The cancer registration dataset includes data on demographics, characteristics of the tumour, patients’ vitality status and basic information regarding the treatment received.We will analyse the data to describe patient characteristics and calculate time to death. We will also calculate a measure called ‘relative survival’, which is an estimate of how the survival among cancer patients compares to that in the general population. This is valuable because not all patients who die may die due to their cancer, and this statistictakes that into account.
• Study status:
  Planned

Research institution and networks

Institutions

Evidera

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 12/11/2018

Actual: 12/11/2018

Study start date

Planned: 01/08/2019

Date of final study report

Planned: 30/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol Myers Squibb Pharmaceuticals Ltd

Study protocol

Initial protocol

ODR_PHE_Cancer_Protocol_v1.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable