Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
27/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Usha Menon

ORCID ID

http://orcid.org/0000-0003-3708-1732

Contact details

Gynaecological Cancer Research Centre
Department of Women’s Cancer
Institute of Women’s Health
UCL
Maple House
1st floor
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)203 447 2108
u.menon@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00058032

Protocol/serial number

Current Version 7.1

Study information

Scientific title

UK Collaborative Trial of Ovarian Cancer Screening

Acronym

UKCTOCS

Study hypothesis

Current hypothesis as of 01/10/2015:
Hypothesis 1 – Preclinical detection by screening can reduce mortality from Ovarian Cancer (OC).
Hypothesis 2 - OC mortality can be reduced without unacceptable physical and psychological morbidity.
Hypothesis 3 - OC mortality can be reduced at an acceptable economic cost to the health service.
Hypothesis 4 - If population screening for OC were introduced compliance would be high enough for an impact on overall mortality from OC to be achievable

Previous hypothesis:
1. To establish the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality
2. To determine the physical morbidity of ovarian cancer screening
3. To determine the resource implications of screening and the interventions which result from screening
4. To record the psychological consequences of screening in the subgroups of true negative, true positive, false negative and false positive screening results
5. To assess the feasibility of population screening for ovarian cancer as reflected by uptake of invitations and compliance rates with annual screening
6. To compare the performance of two screening strategies for ovarian cancer
7. To establish a serum bank for future assessment of novel tumour markers

Ethics approval

North West MREC, 21/06/2000, ref: 00/8/034

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Patient information can be found at: http://www.instituteforwomenshealth.ucl.ac.uk/womens-cancer/gcrc/ukctocs/files/patient-information-sheet.pdf

Condition

Ovarian/tubal and primary peritoneal cancer

Intervention

Three groups:
1. A control group (no screening)
2. A multimodal group (annual screening with serum CA125 interpreted using the Risk of Ovarian Cancer Algorithm (ROCA) as the primary test and CA125 and ultrasound as the secondary test)
3. An ultrasound group (annual screening with ultrasound as the primary test and repeat ultrasound in 6 - 8 weeks as the secondary test)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ovarian cancer mortality at 7 years after randomisation.

Secondary outcome measures

Added 01/10/2015:
1. Performance characteristics of the two screening strategies (serum CA125 versus ultrasound)
2. Physical morbidity resulting from surgical intervention attributable to screening
3. Psychological consequences of screening
4. Resource implications of screening and the resulting interventions
5. Feasibility of screening, as reflected by compliance rates with annual screening
6. Establish a serum bank for future assessment of novel tumour markers

Overall trial start date

04/11/2000

Overall trial end date

31/12/2024

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 50 - 74 years
2. Postmenopausal: either
2.1. Greater than 12 months amenorrhoea following a natural menopause or hysterectomy, or
2.2. Greater than 12 months of hormone replacement therapy (HRT) commenced for menopausal symptoms

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

200,000

Participant exclusion criteria

1. History of bilateral oophorectomy
2. Currently active non-ovarian malignancy. Women who have a past history of malignancy will only be eligible if:
2.1. They have no documented persistent or recurrent disease, and
2.2. They have not received treatment for more than 12 months
3. Women who have had an ovarian malignancy in the past
4. Women at high risk of ovarian cancer due to familial predisposition as defined by the eligibility criteria for the UK Familial Ovarian Cancer Screening Study (UKFOCSS)
5. Women participating in other ovarian screening trials

Recruitment start date

17/04/2001

Recruitment end date

29/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
W1T 7DN
United Kingdom

Trial participating centre

University College London
London
WC1E 6BT
United Kingdom

Trial participating centre

Belfast City Hospital
Belfast
BT9 7AB
United Kingdom

Trial participating centre

St Michael’s Hospital
Bristol
BS2 8EG
United Kingdom

Trial participating centre

University of Wales College of Medicine
Cardiff
CF14 4XN
United Kingdom

Trial participating centre

Derby City General Hospital
Derby
DE22 3NE
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom

Trial participating centre

Liverpool Women’s Hospital
Liverpool
L8 7SS
United Kingdom

Trial participating centre

Royal Free Hospital
London
NW3 2QG
United Kingdom

Trial participating centre

St Bartholomew’s Hospital
London
EC1A 7BE
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Trial participating centre

James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Llandudno General Hospital
Gwynedd
LL30 1LB
United Kingdom

Trial participating centre

Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

St Mary’s Hospital
Portsmouth
W2 1NY
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/jro

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Eve Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publications addressing each of the outcomes are anticipated.

Intention to publish date

01/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16827831
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/19008269
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19282241
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21147030
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21362184
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21762355
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22911637
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22791597
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23456790
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24129231
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24589827
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26095052
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25964255
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25290539

Publication citations

  1. Results

    Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I, Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)., Lancet Oncol., 2009, 10, 4, 327-340, doi: 10.1016/S1470-2045(09)70026-9.

  2. Results

    Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U, Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort., Lancet Oncol., 2011, 12, 1, 38-48, doi: 10.1016/S1470-2045(10)70268-0.

  3. Results

    Sharma A, Gentry-Maharaj A, Burnell M, Fourkala EO, Campbell S, Amso N, Seif MW, Ryan A, Parmar M, Jacobs I, Menon U, , Assessing the malignant potential of ovarian inclusion cysts in postmenopausal women within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a prospective cohort study., BJOG, 2012, 119, 2, 207-219, doi: 10.1111/j.1471-0528.2011.03038.x.

  4. Results

    Gentry-Maharaj A, Taylor H, Kalsi J, Ryan A, Burnell M, Sharma A, Apostolidou S, Campbell S, Jacobs I, Menon U, Validity of self-reported hysterectomy: a prospective cohort study within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)., BMJ Open, 2014, 4, 3, e004421, doi: 10.1136/bmjopen-2013-004421.

  5. Results

    Sharma A, Beveridge HA, Fallowfield LJ, Jacobs IJ, Menon U, Postmenopausal women undergoing transvaginal ultrasound screening prefer not to have chaperones, BJOG, 2006, 113, 8, 954-957.

  6. Results

    Menon U, Gentry-Maharaj A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, Lopez A, Godfrey K, Oram D, Herod J, Williamson K, Seif M, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso N, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Skates S, Parmar M, Jacobs I, Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study, BMJ, 2008, 337, a2079, doi: 10.1136/bmj.a2079.

  7. Results

    Burnell M, Gentry-Maharaj A, Ryan A, Apostolidou S, Habib M, Kalsi J, Skates S, Parmar M, Seif MW, Amso NN, Godfrey K, Oram D, Herod J, Williamson K, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Campbell S, Fallowfield L, Jacobs I, Menon U, Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials, Trials, 2011, 12, 61, doi: 10.1186/1745-6215-12-61.

  8. Results

    Sharma A, Apostolidou S, Burnell M, Campbell S, Habib M, Gentry-Maharaj A, Campbell S, Amso N, Seif MW, Fletcher G, Singh N, Benjamin E, Brunell C, Turner G, Rangar R, Godfrey K, Oram D, Herod J, Williamson K, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Fourkala E-O, Ryan A, Parmar M, Jacobs I, Menon U, Risk of epithelial ovarian cancer in asymptomatic women with ultrasound-detected ovarian masses: a prospective cohort study within the UK collaborative trial of ovarian cancer screening (UKCTOCS), Ultrasound Obstet Gynecol, 2012, 40, 3, 338-344, doi: 10.1002/uog.12270.

  9. Results

    Gentry-Maharaj A, Sharma A, Burnell M, Ryan A, Amso NN, Seif MW, Turner G, Brunell C, Fletcher G, Rangar R, Fallowfield L, Campbell S, Jacobs I, Menon U, Acceptance of transvaginal sonography by postmenopausal women participating in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, Ultrasound Obstet Gynecol, 2013, 41, 1, 73-79, doi: 10.1002/uog.12262.

  10. Results

    Sharma A, Burnell M, Gentry-Maharaj A, Campbell S, Amso NN, Seif MW, Fletcher G, Brunel C, Turner G, Rangar R, Ryan A, Jacobs I, Menon U; United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), Factors affecting visualization of postmenopausal ovaries: descriptive study from the multicenter United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), Ultrasound Obstet Gynecol, 2013 , 42, 4, 472-477, doi: 10.1002/uog.12447.

  11. Results

    Gentry-Maharaj A, Fourkala EO, Burnell M, Ryan A, Apostolidou S, Habib M, Sharma A, Parmar M, Jacobs I, Menon U, Concordance of National Cancer Registration with self-reported breast, bowel and lung cancer in England and Wales: a prospective cohort study within the UK Collaborative Trial of Ovarian Cancer Screening, Br J Cancer, 2013, 109, 11, 2875-2879, doi: 10.1038/bjc.2013.626.

  12. Results

    Sharma A, Burnell M, Gentry-Maharaj A, Campbell S, Amso NN, Seif MW, Fletcher G, Brunell C, Turner G, Rangar R, Ryan A, Jacobs I, Menon U, Quality Assurance and its impact on ovarian visualisation rates in the multicentre United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), Ultrasound Obstet Gynecol, 2015 , doi: 10.1002/uog.14929.

  13. Results

    Menon U, Ryan A, Kalsi J, Gentry-Maharaj A, Dawnay A, Habib M, Apostolidou S, Singh N, Benjamin E, Burnell M, Davies S, Sharma A, Gunu R, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Seif MW, Jenkins H, Mould T, Woolas R, Murdoch JB, Dobbs S, Amso NN, Leeson S, Cruickshank D, Scott I, Fallowfield L, Widschwendter M, Reynolds K, McGuire A, Campbell S, Parmar M, Skates SJ, Jacobs I, Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, J Clin Oncol, 2015 , 33, 18, 2062-2071, doi: 10.1200/JCO.2014.59.4945.

  14. Results

    Gentry-Maharaj A, Karpinskyj C, Glazer C, Burnell M, Ryan A, Fraser L, Lanceley A, Jacobs I, Hunter MS, Menon U, Use and perceived efficacy of complementary and alternative medicines after discontinuation of hormone therapy: a nested United Kingdom Collaborative Trial of Ovarian Cancer Screening cohort study, Menopause, 2015, 22, 4, 384-390, doi: 10.1097/GME.0000000000000330.

Additional files

Editorial Notes

27/01/2016: Publication reference added. On 01/10/2015 the following changes were made to the trial record: 1. The overall trial end date was changed from 03/11/2012 to 31/12/2024. 2. Cancer Research UK, Department of Health and The Eve Appeal were added to the list of funders.