Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical screening (also known as a smear test) involves a doctor or nurse using a small brush to collect cells from the surface of the cervix (the entrance to the womb from the vagina). Detecting and removing abnormal cells can prevent cervical cancer. The cervical screening guidelines recommend a repeat smear after six months, with colposcopy (where a magnifying device is used to look at the cervix) if the mildly abnormal smear persists, and that “colposcopy for all’’ would involve excessive and wasteful intervention and cause unnecessary anxiety for many women. The aim of this study is to determine whether enabling a woman to choose between a management policy of repeat smears or colposcopy produces a better outcome.

Who can participate?
Women aged 20 to 60 with mildly abnormal cervical smear test results

What does the study involve?
Women are randomly allocated to either the choice group or the no-choice group. Women allocated to the no-choice group had a repeat smear at 6 months. If the smear was normal, a further repeat smear was performed at 12 months and if again normal, the women returned to routine screening. If the smear at six months is abnormal, colposcopy is undertaken. Treatment consists of diathermy loop excision, which involves using a thin heated wire loop to remove the area of the cervix where the abnormal cells are. Patients are followed up six months later by means of smear and colposcopy. If the 12-month smear is abnormal following a normal smear at 6 months, then those women are referred for colposcopy and treatment. Women allocated to the choice group choose between colposcopy and a repeat smear at 6 months, after an opportunity to discuss the two options. Those who choose repeat smears are managed exactly as described above for the no-choice group. Women who select colposcopy are managed according to the colposcopy procedure described above.

What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. As it is necessary for those women with an abnormal smear to be referred to the colposcopy clinic, it could be argued that this visit could make them unnecessarily anxious and more so than if they were recalled by the GP.

Where is the study run from?
St Mary’s Hospital by the University of Manchester (UK)

When is the study starting and how long is it expected to run for?
January to December 2002

Who is funding the study?
National Health Service Research and Development Cancer Programme (UK)

Who is the main contact?
Prof. Henry Kitchener
henry.kitchener@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henry Kitchener

ORCID ID

Contact details

Department of Obstetrics & Gynaecology and Reproductive Health
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom
+44 (0)161 276 6421/6461
henry.kitchener@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCP2/R207

Study information

Scientific title

A randomised controlled trial of cytological surveillance versus patient choice between surveillance and colposcopy in managing mildly abnormal cervical smears

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer (neoplasms): Cervix

Intervention

1. Normal procedure of repeat smear in 6 months. If normal, a further repeat smear at 12 months. If smear at 6 months was abnormal, colposcopy was undertaken.
2. Patient choice given between colposcopy and 6-months repeat smear. Women who chose colposcopy were managed as for normal procedure arm.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Women with mildly abnormal cervical smears

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

476

Participant exclusion criteria

Pregnancy or abnormal vaginal bleeding.

Recruitment start date

01/01/2002

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cancer National Research and Development Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/14687054

Publication citations

  1. Results

    Kitchener HC, Burns S, Nelson L, Myers AJ, Fletcher I, Desai M, Dunn G, Maguire P, A randomised controlled trial of cytological surveillance versus patient choice between surveillance and colposcopy in managing mildly abnormal cervical smears., BJOG, 2004, 111, 1, 63-70.

Additional files

Editorial Notes

08/04/2016: Plain English summary added.