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Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women


Phase 2
30 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Edward E. Partridge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000353332

NCT ID:

NCT00080639

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294