Ovarian CancerNCT00033488
Screening Women at High Genetic Risk for Ovarian Cancer
A study testing cytology specimen collection procedure, annual screening and comparison of screening methods in people with Ovarian Cancer, run by University College London Hospitals at 2 sites in United Kingdom.
Trial summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- cytology specimen collection procedure, annual screening and comparison of screening methods
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2000to Mar 2010
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following:
- Family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships
- Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships
- Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships
- Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes
- Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships
- Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed
PATIENT CHARACTERISTICS:
Age:
- 35 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- No prior bilateral oophorectomy
Other:
- No concurrent participation in other ovarian cancer screening trials
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Institute of Child Health
London, England, WC1N 1EH
About this study
Official title: The UK Familial Ovarian Cancer Screening Study
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.
PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.
Read the detailed description
OBJECTIVES:
- Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.
- Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
- Assess the feasibility of screening this high-risk population in terms of compliance rates.
OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.
- Conditions
- Ovarian Cancer
- Being tested
- cytology specimen collection procedure, annual screening, comparison of screening methods
- 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.
cytology specimen collection procedureOther
annual screeningProcedure or surgery
comparison of screening methodsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2000
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- James Mackay, MD, MA, FRCP, FRCPE, Study chair, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033488
- Sponsor's protocol ID
- CDR0000069292
- Other IDs
- UKFOCSS, CRCA-FOCS, EU-20044
- Status last verified
- Jun 2007
- First submitted
- 9 Apr 2002
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UK Familial Ovarian Cancer Screening Study
- ClinicalTrials.gov ID
- NCT00033488
- Acronym / sponsor ID
- CDR0000069292
- Conditions
- Ovarian Cancer
- Keywords
- ovarian epithelial cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Sep 2000
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.
PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.
Detailed description
OBJECTIVES:
- Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.
- Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
- Assess the feasibility of screening this high-risk population in terms of compliance rates.
OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytology specimen collection procedure | Other | – |
| annual screening | Procedure or surgery | – |
| comparison of screening methods | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Mackay, MD, MA, FRCP, FRCPE study chair
Institute of Child Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytology specimen collection procedure, annual screening and comparison of screening methods in people with Ovarian Cancer, run by University College London Hospitals at 2 sites in United Kingdom.
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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
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 18 Dec 2013.