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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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.

  1. Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.

    Measured: baseline

  2. 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)
  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.

  1. First posted8 Apr 2004 (estimated)
  2. Study startJun 2003
  3. Primary completionJun 2007
  4. Study completionJun 2007

Why it stopped: Terminated for administrative reasons and becuase there were no enrollments

Resources

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)
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

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.

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