International Ovarian Tumour Analysis (IOTA) Phase 5

• Research type

  Research Study

• Full title

  International Ovarian Tumour Analysis (IOTA) Phase 5 A multicentre study on the pre­operative characterisation of ovarian tumours and conservative management of benign­ looking adnexal masses

• IRAS ID

  129711

• Contact name

  Nandita Deo

• Contact email

  Nandita.Deo@bartshealth.nhs.uk

• Sponsor organisation

  Joint Research Management Office

• Research summary

  The medium to long term behaviour of benign­ looking adnexal masses that do not undergo surgery is unknown. It is rarely possible for that these masses to undergo malignant transformation, rupture or torsion. Furthermore they may undergo changes in volume and/or morphology that may or may not predict any of these behaviours. To date, no research has rigorously investigated the long­term behaviour of such masses. Consequently, there are no evidence­ based guidelines on the optimal management of the majority of adnexal tumours. It is therefore not surprising that clinical practice is highly variable, with some clinicians preferring to operate on virtually any mass. When a clinician decides not to operate, the time intervals selected for follow up scans is arbitrarily chosen. On the other hand, we do have some convincing data to suggest that simple cysts are rarely malignant and so it is generally thought that operating on these common tumours is probably not necessary and simply increases costs and morbidity. Developing new insights into the natural evolution of benign looking conservatively managed ovarian masses would potentially change the management of thousands of women, avoid surgery or even further surveillance for some and detect
  cancer earlier or even prevent it for others.
  In this international multicentre study IOTA Phase 5 we aim to develop the optimal evidence­ based algorithm for the management of all adnexal tumours in order to improve the early detection of ovarian cancer while at the same time reducing the number of unnecessary operations. At least three thousand patients with an adnexal mass will undergo an ultrasound examination and if no operation is needed they will be followed up for at least 5 years. At each visit the investigator will assess the tumour and decide whether surgery is necessary based on the available information. Survival and logistic regression analysis will be used to develop decision aids to assist clinicians in making decisions regarding surgery and follow up. Eventually we aim to reduce mortality, morbidity, and costs.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  13/LO/0975

• Date of REC Opinion

  23 Jul 2013

• REC opinion

  Further Information Favourable Opinion