Ovarian CancerNCT00080639
CA-125 in Screening Patients at High Risk for Ovarian Cancer
An observational study of Ovarian Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- physiologic testing and study of high risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2007
- Phase
- Observational
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women know to be at high risk for ovarian cancer
DISEASE CHARACTERISTICS:
- At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
- Family history of at least 2 ovarian or breast* cancers among the patient and first- and second-degree relatives within the same lineage**
- If breast cancer* is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) NOTE: **Multiple primary cancers in the same person satisfies this criterion
- Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
- Prior breast cancer* diagnosis
- One first-degree or 2 second-degree relatives with breast* or ovarian cancer
- If breast cancer is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)
- Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
- This criterion includes the following situations for which BRCAPRO is not required:
- Tested positive for a BRCA1 or BRCA2 mutation (100% probability)
- First- or second-degree relative with a BRCA1 or BRCA2 mutation NOTE: *Including ductal carcinoma in situ
- No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum
PATIENT CHARACTERISTICS:
Age
- 30 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- No hemophilia
- No other bleeding disorders
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
- No emphysema
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric or psychological condition that would preclude giving informed consent
- No concurrent untreated malignancy except nonmelanoma skin cancer
- No other medical condition that would preclude blood draws (e.g., chronic infectious disease)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 months since prior adjuvant chemotherapy for cancer
Endocrine therapy
- Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed
Radiotherapy
- More than 3 months since prior adjuvant radiotherapy for cancer
Surgery
- More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
- Prior prophylactic oophorectomy allowed
Other
- More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
- No concurrent participation in other ovarian cancer early detection trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
About this study
Official title: Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.
PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
- Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Secondary
- Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.
Patients are followed at 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.
- Conditions
- Ovarian Cancer
- Being tested
- physiologic testing, study of high risk factors
- 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.
physiologic testingOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
Measured: baseline
Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Measured: baseline
Secondary outcomes (1)
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJun 2003
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Terminated for administrative reasons and becuase there were no enrollments
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward E. Partridge, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080639
- Sponsor's protocol ID
- CDR0000353332
- Other IDs
- UAB-120, UAB-0120
- Status last verified
- Aug 2013
- First submitted
- 7 Apr 2004
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
- ClinicalTrials.gov ID
- NCT00080639
- Acronym / sponsor ID
- CDR0000353332
- Conditions
- Ovarian Cancer
- Keywords
- ovarian epithelial cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated for administrative reasons and becuase there were no enrollments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Apr 2004 (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: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.
PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
- Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Secondary
- Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.
Patients are followed at 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women know to be at high risk for ovarian cancer
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 |
|---|---|---|
| physiologic testing | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
Time frame: baseline
Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Time frame: baseline
1 secondary outcome
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Edward E. Partridge, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by University of Alabama at Birmingham at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. (time frame: baseline). 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?
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 5 Aug 2013.