Back to Ovarian Cancer
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00043472

NCT00043472
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You are 30 years of age or older
  • You have never been diagnosed with ovarian cancer (including borderline ovarian tumors) or a related cancer called primary papillary serous carcinoma of the peritoneum
  • You still have at least one ovary
  • You have signed a consent form allowing your personal health information to be used
  • You meet at least one of the following family history or genetic risk conditions:
    • A harmful change (mutation) in the BRCA1 or BRCA2 gene has been found in your family, and either you yourself have tested positive for it, or a close relative (parent, sibling, child, grandparent, aunt/uncle, niece/nephew) has tested positive
    • You or your close relatives (on the same side of the family) have had at least two cases of ovarian and/or breast cancer, and if breast cancer is part of this, at least one case was diagnosed before menopause (or before age 50 if menopause age is unknown)
    • You are of Ashkenazi Jewish heritage and have at least one parent/sibling/child, or two grandparents/aunts/uncles, who have had breast or ovarian cancer (with at least one breast cancer diagnosed before menopause or before age 50 if unknown)
    • You are of Ashkenazi Jewish heritage and you yourself have had breast cancer diagnosed before menopause (or before age 50 if menopause age is unknown)
    • A specialist calculation tool called BRCAPRO estimates your chance of carrying a BRCA1 or BRCA2 mutation at more than 20%, based on your family's cancer history (confirm with trial site)

Who may not be able to join:

  • A close relative has a known harmful BRCA1 or BRCA2 mutation, and you have already been tested and shown not to carry that exact same mutation
  • You are currently pregnant or planning to become pregnant during the study
  • You are already taking part in another ovarian cancer early detection study (with one specific exception — confirm with trial site)
  • You have a psychiatric or psychological condition that would prevent you from giving fully informed consent
  • You currently have an untreated cancer (other than certain common skin cancers)
  • You have received chemotherapy, radiation therapy, or certain targeted cancer treatments within the past month (31 days)
  • You have been treated for cancer that had spread to other parts of the body within the past 5 years
  • You have had surgery inside your abdomen (including keyhole/laparoscopic surgery) within the past 3 months
  • You have already had both ovaries removed
  • You have a medical condition that makes donating blood for research unsafe, such as a chronic infectious disease, severe anaemia, or a bleeding disorder like haemophilia

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
National Cancer Institute (NCI)
Registry
clinicaltrials_gov
Start date
9 July 2003

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the prospective incidence of ovarian cancer, breastcancer, primary peritoneal carcinoma, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on womenwho are known BRCA1/2 mutation carriers; To assess prospectively the prevalence of clinically occult ovarian cancer and fallopian tube cancer among women undergoingprophylactic salpingooophorectomy, and to seek evidence of precursor lesions in the excised ovaries and fallopian tubes...; To quantify the positive predictive value and specificity of the Risk of Ovarian Cancer Algorithm (ROCA) based on...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov