HELP-ER

• Research type

  Research Study

• Full title

  Prospective Study of HE4 serum Level in Patients with First Relapsed Ovarian Cancer

• IRAS ID

  276226

• Contact name

  C Fotopoulou

• Contact email

  c.fotopoulou@imperial.ac.uk

• Sponsor organisation

  Charité – Medical University Berlin

• Duration of Study in the UK

  6 years, 6 months, 26 days

• Research summary

  International, non-interventional, multicentre trial, first conduct of a retrospective study (part A) followed by prospective study (part B).

  This is a retrospective (hypothesis generating) / prospective,multicentre, non-interventional observational trial performed in 2 stages for patients with first ovarian cancer relapse with a Platinum Free interval ≥ 6 months.
  The study has the aim to improve the clinical management of first platinum sensitive ovarian cancer relapse by improving the AGO Score for resectability which is a useful predictor for operability in patients with ovarian cancer by adding HE4 serum concentrations and CA125 level which will be used to develop a new algorithm (HELP-ER Score).
  In the first step (part A) an algorithm will be developed on a retrospective cohort of about 188 patients from Tumour Bank Ovarian Cancer (TOC) - network (6 sites from 4 different countries). Clinical data will be combined with biomarkers to develop an algorithm to predict surgical outcome.

  The algorithm will be validated within the prospective study (part B) where samples will be taken from patients and analyse at the Charité – Medical University Berlin.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  20/SC/0162

• Date of REC Opinion

  29 May 2020

• REC opinion

  Further Information Favourable Opinion