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Screening Study for Ovarian Cancer in Women Who are at High Genetic Risk for Developing Ovarian Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Screening Women at High Genetic Risk for Ovarian Cancer
Basic Trial Information
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Protocol IDs
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No phase specified
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Screening
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Active
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35 and over
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Other
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UKFOCSS
CRCA-FOCS, EU-20044, NCT00033488
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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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: Radiotherapy: Surgery: - No prior bilateral oophorectomy
Other: - No concurrent participation in other ovarian cancer screening
trials
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: Expected Enrollment 5000A total of 5,000 patients will be accrued for this study. 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
Trial Contact Information
Trial Lead Organizations University College Hospital | | | | James Mackay, MD, MA, FRCP, FRCPE, Protocol chair | | | |
Trial Sites
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| United Kingdom |
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| England |
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London |
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| | | | | Institute of Child Health |
| | | James Mackay, MD, MA, FRCP, FRCPE | |
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j.mackay@ich.ucl.ac.uk |
| | | Saint Bartholomew's Hospital |
| | | Ian Jacobs, MD | |
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| Registry Information | | | Official Title | | The UK Familial Ovarian Cancer Screening Study | | | Trial Start Date | | 2000-09-01 | | | Registered in ClinicalTrials.gov | | NCT00033488 | | | Date Submitted to PDQ | | 2002-02-12 | | | Information Last Verified | | 2007-06-11 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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