Treatment of Metastatic or Recurrent Cervical Cancer in England

• Research type

  Research Study

• Full title

  Patient Characteristics and Treatment Patterns of Metastatic or Recurrent Cervical Cancer Patients in England – A Cohort Study Using the National Cancer Registration and Analysis Service Datasets

• IRAS ID

  266680

• Sponsor organisation

  Certara- Evidence and Access (previously Analytica Laser, a Certara company)

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  In the UK, cervical cancer is the 14th most common cancer in women. It has an age-standardised incidence rate of 9.6/100,000 accounting for 3186 cases in 2016 in England.
  Treatment practices in early stages of cervical cancer are fairly established and comprise of surgery combined with radiation and concurrent platinum based chemotherapy; however, as the disease becomes metastatic or recurrent, the role of chemotherapy becomes palliative in nature. There is no clear evidence of impact of chemotherapies on overall survival in metastatic/recurrent cervical cancer. There is a critical need to evaluate the public health burden of patients with metastatic/recurrent cervical cancer utilizing current treatment and to set a benchmark for future assessments.
  This retrospective cohort study aims to describe the clinical characteristics, disease background, treatment patterns and associated survival of patients diagnosed with metastatic or recurrent cervical cancer. The study population for England will be obtained from the National Cancer Registration and Analysis Service (NCRAS). It manages several linked data sources for cancer research. These include the Cancer Registration Data sets, Systemic Anti Cancer Treatment (SACT) data set, Radiotherapy Data Set (RTDS), and Hospital Episode Statistics (HES). These are population-level data sets for the whole of England which has a population of 56 million individuals (2016). Patients will be selected using a set of eligibility criteria to be applied between 01/04/2012 to 31/03/2017 over a 5 year period with each of them having at least 1 years follow up data, unless any died earlier or migrated. Therefore, data up 31/03/2018 (last available date on SACT) will be used for follow up. Patients’ baseline characteristics will be obtained from the data sets going back to 01/04/2011. The study observation period is therefore between 01/04/2011 and 31/03/2018. The approach to analysing the data will be descriptive and will not involve hypothesis testing.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  19/NE/0279

• Date of REC Opinion

  28 Aug 2019

• REC opinion

  Favourable Opinion