Patient recruitment for observational and interventional research studies in anal cancer in Leeds, England for 2013-2018


Year:

Session type:

Theme:

Robert Samuel1,David Sebag-Montefiore2,Katie Spenver1,Alex Gilbert1,Nathalie Casanova3,Rachel Cooper3,Louise Loughman3,Pamela Shuttleworth3
1University of Leeds,2Universit of Leeds,3Leed University Teaching Hospitals NHS Foundation Trust

Abstract

Background

Anal cancer is rare but its incidence is rising with around 1,200 people diagnosed per year in the UK. In colorectal cancer, sustained patient participation rates of ≥16% in interventional research  studies is associated with improved survival for the whole patient population. We evaluate recruitment for the non-surgical management of anal cancer with regards to trial type and proportion of patients recruited.

Method

Study recruitment data was searched on electronic medical records for all patients with a new diagnosis of anal cancer who had radical treatment 01/01/13-31/12/18.

Results

Table 1 shows number of patients approached and entered for observational and interventional trials split by year of diagnosis. This shows a decline in recruitment for observational studies and an increase in recruitment for interventional studies over time. Total number approached and proportion of approached that entered an interventional study improved over time. 44 patients over the 6 year period were approached and/or entered more than 1 observational trial. No patients were involved in >1 interventional trial. In 2017-2018, 30% of incident patients entered an interventional trial.

Year

2013

2014

2015

2016

2017

2018

Number of new diagnosis

45

42

42

47

47

44

Observational

Approached

9

140*

56

12

9

10

Entered

9

100

50

12

6

9

Interventional

Approached

0

0

4

0

18

19

Entered

0

0

2

0

12

15

 

 

 

 

 

 

 

Table 1 - Anal cancer data 2013-2018 split by trial type and recruitment status

*Large recruitment for 2014 is due to a patient-reported outcome study that recruited patients who were post treatment (including those diagnosed pre-2014)

Conclusion

Overall recruitment, proportion of patients approached and proportion of those approached that entered an interventional study improved overtime. We have demonstrated that high participation rates in interventional trials of a rare cancer is possible and aim to sustain and increase our recruitment in the future.