4707S-08: OCEDP

Ovarian Cancer Early Detection Program

Type of Study
Cancer (Oncology) - Cancer Detection Program
Location
First Hill Campus
Short Description

The detection of ovarian cancer early, when it is confined to the ovary and potentially curable, is an important clinical objective. The Ovarian Cancer Early Detection Screening Program will offer twice yearly CA125 blood tests and annual ultrasounds to monitor women at high risk for ovarian cancer.

The purpose of the screening program is threefold:

  1. To provide screening for women at high risk for developing ovarian cancer;
  2. To build a repository of well-characterized blood specimens for use in ovarian cancer research, and
  3. To provide a genetics counseling session to help educate women about risk-reducing options. This cohort of women will be among the first in the nation with access to novel biomarkers when they become available for use in screening for ovarian cancer
Status
Open
Principal Investigator
Pamela Paley, M.D.
Eligibility Notes
Key Inclusion Criteria:
  • The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at least one breast cancer must be pre-menopausal (age at diagnosis = 50 if age at menopause unknown).

OR


  • The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer. Where breast cancer is required to meet this criterion, at least one breast cancer must be pre-menopausal (age at diagnosis = 50 if age at menopause unknown).

OR

  • Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
  • This criterion includes the following situations for which BRCAPRO is not explicitly required:
  • The subject has tested positive for a BRCA1 or BRCA2 mutation. (100% probability)
  • The subject has a first or second degree relative with a BRCA 1/2 mutation.

Key Exclusion Criteria:
  • The subject is/has/has had:
    • Ovarian cancer or peritoneal carcinomatosis.
    • A first- or second-degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation
    • The participant has no ovaries
    • Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed.
    • Currently pregnant
    • Psychiatric or psychological or other conditions which prevent a fully informed consent
    • Current untreated malignancy (other than non-melanoma skin cancer)
    • Currently receiving adjuvant chemotherapy or radiation therapy for cancer
    • (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
    • Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
    • Intraperitoneal surgery within the last 3 months (laparoscopy or laparotomy).

  • A history of any medical conditions that would place subject at risk as a result of the blood donation.
  • Such conditions include but are not limited to:
    • hemophilia or other bleeding disorders,
    • chronic infectious disease,
    • emphysema
    • serious anemia.
  • Women with a previous history of breast cancer including those taking tamoxifen, are eligible if exclusion criteria 7,8 & 9 do not apply.
Contact Name
Research Coordinator
Phone
(800) 328-1124
Alternate Phone
(206) 215-6200
Email
info@marsharivkin.org