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Study Design

Case control study

Primary:

To establish a case control series for:

  • Detection of genes with moderate penetrance for ovarian cancer using single nucleotide polymorphisms (SNP study)
  • Assessment of biomarker profile of ovarian cancer cases pre, post-op and following chemotherapy (Biomarker study)
  • Identification of which symptoms or medical complaints are common in women with ovarian cancer when compared to women who do not have the disease (Symptoms study)

Secondary:

  • Build a model of individualised ovarian cancer risk rediction based on the genetic and biomarker profiles
  • To establish a serum bank for future assessment of novel tumour markers

Between 2006 and 2010, 4,823 women were recruited to the study. The ovarian cancer cases were recruited from gynaecological oncology clinics (1,200 in total) either before treatment or during routine follow up. The controls were recruited from the multimodal arm of UKCTOCS, where women were approached to take part in this separate study at one of their annual screening appointments on the trial. Women with benign conditions were recruited mainly for the biomarker studies.

Inclusion criteria:

Cases

  • Women with an adnexal mass suspicious of ovarian cancer who are about to undergo surgery
  • Women with a confirmed diagnosis of primary invasive or borderline ovarian cancer
  • Women with a probable diagnosis of primary invasive ovarian cancer who are not undergoing surgery

Controls

  • Women with a possible benign or borderline adnexal mass who are about to undergo surgery
  • Apparently healthy women recruited from the Multimodal arm of UKCTOCS when they attend for annual screening

Exclusion criteria for healthy controls (no exclusion criteria for the cases) - History of bilateral oophorectomy

 

Biobank

The biobank consists of plasma, serum, DNA and formalin fixed paraffin embedded (FFPE) blocks. The participants were flagged using their NHS number through either the National Health Service Central Register for England and Wales or the Cancer Registry of Northern Ireland depending upon their place of residence until February 2016. The end date of the study is 31st Dec 2024

Funders