Trial of managment of Borderline and Other Low-grade Abnormal smears. (TOMBOLA)

Lead Research Organisation: University of Aberdeen
Department Name: Unlisted

Abstract

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

Technical Summary

A randomised trial is proposed:
1. To determine whether a policy of cytological surveillance or initial colposcopy is the more effective and efficient policy for further investigation and clinical managment in women with mild or borderline cervical dyskaryosis.
2. To determine whehter, following colposcopic examination of women with mild or borderline dyskaryosis, immediate large loop excision of the transformation zone (LLETZ) or biopsy and recall if appropriate for LLETZ, is more effective and efficient method of treatment.
3. To evaluate the contribution of human papillomavirus (HPV) testing to the effectivness and efficiency of the existing procedures for managment of women with mild or borderline dyskaryosis;
We propose that the study population comprises
1. Women with an index borderline smear followed by another smear, six months later, which shows either borderline or mild dyskaryosis;
2. Women with an index smear classified as mildly dyskaryotic
The proposed trial is timely as there is an opportunity to determine whether HPV testing could be effective in the triage of women with mild or borderline dyskaryosis, while keeping women and clinicians participating in the trial blind to the results of such testing.

Publications

10 25 50

publication icon
Cotton S (2011) After-effects reported by women having follow-up cervical cytology tests in primary care: a cohort study within the TOMBOLA trial. in The British journal of general practice : the journal of the Royal College of General Practitioners

publication icon
Cotton SC (2015) A normal colposcopy examination fails to provide psychological reassurance for women who have had low-grade abnormal cervical cytology. in Cytopathology : official journal of the British Society for Clinical Cytology

publication icon
Cruickshank ME (2015) Authors' reply. in BJOG : an international journal of obstetrics and gynaecology

publication icon
Cruickshank ME (2015) Management of women with low grade cytology: how reassuring is a normal colposcopy examination? in BJOG : an international journal of obstetrics and gynaecology

 
Guideline Title Colposcopy and Programme Management
Description Citation in NHS CSP Document 20 on colposcopy and programme management
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact Recomendation on management of women with low grade smears and recognition of adverse effects of colposcopy. Re-organisation of NHS England and Public Health England have delayed publication and dissemination of this document.
URL http://www.cancerscreening.nhs.uk/cervical/publications/nhscsp20.html
 
Description Confidential expert review group on Scottish Cervical Screening Programme reporting to Scottish Government
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Gave evidence to a government review
 
Title Biosample bank 
Description Residual sample material from cervical specimens 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact MTA and ethics in progress for collaboration with international reserach groups. 
 
Title Questionnaires (POSM) 
Description Devlopment of context specific questionnaires to assess impact of screening smear result 
Type Of Material Data analysis technique 
Year Produced 2008 
Provided To Others? Yes  
Impact Used to assess impact in different patient group (women with microinvasive cervical cancer). Published results have prompted national audit in UK under auspices of NHS CSP. 
 
Description CSO and NHS Research Forum 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Ran 2 wrokshops with about 50 participants in each

Workshop only ran last week
Year(s) Of Engagement Activity 2013
 
Description Media (as a channel to the public) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Press release

newspaper articles
Year(s) Of Engagement Activity 2009
 
Description Podcast 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Patients, carers and/or patient groups
Results and Impact Popular download from RCOG and BJOG website for non-expert groups

Wider audience reached in relation to screening programme than by specialist journals
Year(s) Of Engagement Activity 2010
 
Description Public and trial participant dissemination TOMBOLA results on website 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact We received no online or telephone enquries

We have been unable to asssess access
Year(s) Of Engagement Activity 2009