Ovarian Cancer Trial, Recruiting NCT04251052 Sponsor: NRG Oncology Condition: Ovarian Cancer
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Ovarian Cancer Trial, Recruiting

NCT04251052
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 35 and 50 years old (inclusive)
  • People who are planning to have both ovaries and fallopian tubes surgically removed to reduce cancer risk, OR people who have been fully counselled about that surgery but have chosen to delay or decline it and are instead having only their fallopian tubes removed for now
  • People who have at least one ovary and fallopian tube still in place at the time of joining the trial (previous removal of the uterus alone is allowed, as is previous tubal ligation, as long as one ovary and fallopian tube with its fimbria — the fringe-like end — remain)
  • People who have a confirmed gene test result, from an approved laboratory, showing a harmful or likely harmful change in the BRCA1 gene, with written documentation of that result
  • People who are either still having periods or have gone through menopause
  • People who have had a pelvic ultrasound or pelvic MRI scan, and a CA-125 blood test (a marker sometimes associated with ovarian conditions), within the past 180 days before joining
  • People who are currently pregnant, or who plan to become pregnant in the future through assisted reproductive technologies, provided they have received proper counselling — including that natural pregnancy will no longer be possible after the surgery
  • People who are currently pregnant and plan to have their fallopian tubes removed during a planned caesarean section
  • Consent must be given by the patient or their legally authorised representative before entering the study

Who may not be able to join:

  • People with a history of any cancer who have received chemotherapy (cell-killing drug treatment) in the past 30 days, or radiotherapy to the abdomen or pelvis at any point in the past (note: certain ongoing maintenance therapies — including hormone therapy, HER2-targeted therapy, immune checkpoint inhibitors, and PARP inhibitor therapy — are permitted; confirm with trial site)
  • People with a prior history of ovarian cancer, including borderline ovarian tumours, primary peritoneal cancer, or fallopian tube cancer
  • People who are not medically well enough to safely undergo the planned surgery
  • People whose recent pelvic ultrasound, pelvic MRI, or CA-125 blood test results are concerning for a possible hidden or visible pelvic cancer — specifically:
    • A pelvic scan showing features suspicious for ovarian cancer (simple cysts of any size, or complex cysts considered likely to be non-cancerous, do not disqualify someone)
    • A CA-125 blood level above 50 U/ml in people who are still having periods and not taking the contraceptive pill; above 40 U/ml in people still having periods who are taking the contraceptive pill; or above 35 U/ml in people who have gone through menopause

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
NRG Oncology
Registry
ClinicalTrials.gov
Start date
1 September 2020
Est. completion
30 June 2047

Where this trial is recruiting

🇨🇦 Canada 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers

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: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov