AzTrials
AzTrials

Ovarian CancerUKCTOCSNCT00058032

CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

A study testing screening questionnaire administration and annual screening in people with Ovarian Cancer, run by University College, London.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is more effective in detecting ovarian cancer early thereby impacting on the mortality from the disease in postmenopausal women from the… Read more about this study

Who is it for?
Ages 50 to 74 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer
What is being tested?
screening questionnaire administration and annual screening
Type of treatment
Surgery or procedure
How many people
202,638 participants
Where
No sites listed yet
Study dates
17 Apr 2001to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Postmenopausal, as defined by meeting 1 of the following criteria:
  • More than 12 months of amenorrhea after natural menopause or hysterectomy
  • Received more than 12 months of hormone replacement therapy for menopausal symptoms
  • No prior ovarian malignancy
  • No prior bilateral oophorectomy
  • Not at high risk for ovarian cancer due to familial predisposition as defined by the UKCCCR Familial Ovarian Cancer Screening Study

PATIENT CHARACTERISTICS:

Age

  • 50 to 74

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No active non-ovarian malignancy
  • Prior malignancy allowed provided there is no documented persistent or recurrent disease and patient has not received treatment for more than 1 year

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No concurrent participation in any other ovarian cancer screening study

About this study

Official title: United Kingdom Collaborative Trial Of Ovarian Cancer Screening

RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is more effective in detecting ovarian cancer early thereby impacting on the mortality from the disease in postmenopausal women from the general population.

PURPOSE: Randomized clinical trial to assess the impact of screening using a multimodal strategy using CA125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA) followed by transvaginal ultrasound as a second line test versus transvaginal ultrasound on mortality from the disease in postmenopausal women from the general population.

Read the detailed description

OBJECTIVES:

  • Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women.
  • Determine the physical morbidity of ovarian cancer screening in this population.
  • Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population.
  • Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population.
  • Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies.
  • Compare the performance of these screening strategies in this population.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.

  • Arm I: Participants do not undergo screening.
  • Arm II: Participants undergo screening with an annual CA 125 level interpreted using the Risk of Ovarian Cancer Algorithm (ROCA). Depending on the results of the test, some patients may undergo additional screening.
  • Arm III: Participants undergo screening with an annual transvaginal or transabdominal ultrasound. Depending on the results of the test, some patients may undergo additional screening.

Participants in all arms complete a health questionnaire at 3-5 years after study entry and in 2014.

PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 5 years.

Conditions
Ovarian Cancer
Being tested
screening questionnaire administration, annual screening
Keywords
ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • screening questionnaire administrationOther

  • annual screeningProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014.

  2. Long term impact of screening on ovarian cancer mortality in the UKCTOCS (LTFU UKCTOCS) (2015-2021): Death due to ovarian cancer (WHO 2014) determined by independent outcomes committee review till 30 June 2020.

Secondary outcomes (5)

  1. Performance characteristics: Sensitivity, specificity, positive predictive values of the two screening strategies (multimodal and ultrasound) for detection of ovarian cancer diagnosed within one year of last screen.

    Ovarian cancer diagnosis is based on outcomes review of medical notes of all women who developed ovarian cancer during the trial.

  2. Surgical complications in women who underwent false positive surgery and were found to have benign or normal adnexae.

    This is assessed through central medical note review and assigned by designated trial gynaecological oncologist.

  3. Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm.

    Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm: (a) Incremental cost-effectiveness analysis over the 14 year period of the trial (censorship 31st Dec 2014); (b) Incremental cost-effectiveness analysis for the cumulative mortality estimated over a 25-year period by extrapolating beyond the 14 years of the trial

  4. Compliance with annual screening: The proportion of women who attended all tests that formed part of an annual screening episode of the total who were eligible for that annual screening episode.

  5. Psychological morbidity related to screening - assessed in a separate MRC funded study, UKCTOCS Psychosocial study, PI Prof Dame Lesley Fallowfield.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study start17 Apr 2001
  3. Primary completion29 Sep 2005
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
202,638 participants randomised to: Multimodal Group: 50640 Ultrasound Group: 50639 Control Group: 101359
Masking
None (open label)
Enrolment
202,638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058032
Sponsor's protocol ID
CDR0000285690
Other IDs
UKCTOCS, EU-20249
Acronym
UKCTOCS
Status last verified
Nov 2020
First submitted
7 Apr 2003
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.

    PubMed 21147030

  • 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 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.

    PubMed 19282241

  • Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, Amso NN, Apostolidou S, Benjamin E, Cruickshank D, Crump DN, Davies SK, Dawnay A, Dobbs S, Fletcher G, Ford J, Godfrey K, Gunu R, Habib M, Hallett R, Herod J, Jenkins H, Karpinskyj C, Leeson S, Lewis SJ, Liston WR, Lopes A, Mould T, Murdoch J, Oram D, Rabideau DJ, Reynolds K, Scott I, Seif MW, Sharma A, Singh N, Taylor J, Warburton F, Widschwendter M, Williamson K, Woolas R, Fallowfield L, McGuire AJ, Campbell S, Parmar M, Skates SJ. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016 Mar 5;387(10022):945-956. doi: 10.1016/S0140-6736(15)01224-6. Epub 2015 Dec 17.

    PubMed 26707054

  • 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 Jun 20;33(18):2062-71. doi: 10.1200/JCO.2014.59.4945. Epub 2015 May 11.

    PubMed 25964255

  • 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 Nov 13;337:a2079. doi: 10.1136/bmj.a2079.

    PubMed 19008269

  • Dilley J, Gentry-Maharaj A, Ryan A, Burnell M, Manchanda R, Kalsi J, Singh N, Woolas R, Sharma A, Williamson K, Mould T, Fallowfield L, Campbell S, Skates SJ, McGuire A, Parmar M, Jacobs I, Menon U. Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecol Oncol. 2023 Dec;179:123-130. doi: 10.1016/j.ygyno.2023.11.005. Epub 2023 Nov 18.

    PubMed 37980767

  • Menon U, Gentry-Maharaj A, Burnell M, Apostolidou S, Ryan A, Kalsi JK, Singh N, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Dawnay A, Parmar M, Jacobs IJ; UKCTOCS team. Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials. Health Technol Assess. 2023 Aug;29(10):1-48. doi: 10.3310/CLDC7214.

    PubMed 37843101

  • Menon U, Gentry-Maharaj A, Burnell M, Ryan A, Singh N, Manchanda R, Kalsi JK, Woolas R, Arora R, Casey L, Dawnay A, Sharma A, Williamson K, Apostolidou S, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar MKB. Tumour stage, treatment, and survival of women with high-grade serous tubo-ovarian cancer in UKCTOCS: an exploratory analysis of a randomised controlled trial. Lancet Oncol. 2023 Sep;24(9):1018-1028. doi: 10.1016/S1470-2045(23)00335-2.

    PubMed 37657461

  • Menon U, Gentry-Maharaj A, Burnell M, Singh N, Ryan A, Karpinskyj C, Carlino G, Taylor J, Massingham SK, Raikou M, Kalsi JK, Woolas R, Manchanda R, Arora R, Casey L, Dawnay A, Dobbs S, Leeson S, Mould T, Seif MW, Sharma A, Williamson K, Liu Y, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar M. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021 Jun 5;397(10290):2182-2193. doi: 10.1016/S0140-6736(21)00731-5. Epub 2021 May 12.

    PubMed 33991479

  • Russell MR, Graham C, D'Amato A, Gentry-Maharaj A, Ryan A, Kalsi JK, Whetton AD, Menon U, Jacobs I, Graham RLJ. Diagnosis of epithelial ovarian cancer using a combined protein biomarker panel. Br J Cancer. 2019 Sep;121(6):483-489. doi: 10.1038/s41416-019-0544-0. Epub 2019 Aug 7.

    PubMed 31388184

  • Fraser L, Burnell M, Salter LC, Fourkala EO, Kalsi J, Ryan A, Gessler S, Gidron Y, Steptoe A, Menon U. Identifying hopelessness in population research: a validation study of two brief measures of hopelessness. BMJ Open. 2014 May 30;4(5):e005093. doi: 10.1136/bmjopen-2014-005093.

    PubMed 24879829

Questions about this trial

What is this clinical trial studying?

A study testing screening questionnaire administration and annual screening in people with Ovarian Cancer, run by University College, London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058032, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

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