PREDICT-GTN v1.0
Research type
Research Study
Full title
Predicting ResistancE and relapse of Disease In patients treated with primary ChemoTherapy for Gestational Trophoblastic Neoplasia (PREDICT-GTN)
IRAS ID
190757
Contact name
Victoria Parker
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
148274, URMS ID number
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Gestational Trophoblastic Neoplasia (GTN) is a rare complication of pregnancy involving an overgrowth of the placenta. The diagnosis includes several conditions, with one in every ten patients needing treatment with chemotherapy or surgery.
Patients are divided into low and high-risk treatment groups based upon a classification system developed by the World Health Organisation (WHO). This helps to decide if they are likely to respond to their chemotherapy. Amongst patients who score 6 (top end of the low-risk group), 85 out of 100 are resistant to the initial chemotherapy and will need more treatment. This is devastating for young women, who have significant side effects and a longer delay before they can try for another child.
The research aims to try and predict which patients do not respond to their first (initial) chemotherapy treatment by:
(1) Analysing two anonymised databases of approximately 7,000 women treated in Sheffield and London between 1973 and 2015 to study how effective the existing WHO scoring system is. Then, a variety of statistical modelling techniques will be used to try and make improvements.
(2) Investigating the role of a substance found in the blood called microRNA in up to 120 women, including patients newly diagnosed with GTN. This will compare the levels of microRNA in blood samples collected at their first visit, 6 weeks and 6 months after their treatment.
We hope that these two approaches will ultimately improve the care of women diagnosed with GTN, and will allow doctors to more accurately decide which chemotherapy will work.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0292
Date of REC Opinion
30 Aug 2016
REC opinion
Favourable Opinion