CompletedNot Applicable

Risk of Ovarian Cancer in Patients With a Pelvic Mass

United States566 participantsStarted 2005-12

Plain-language summary

The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass); * Pre- and post-menopausal women greater than or equal to 18 years of age; * Pelvic mass must be demonstrated by ultrasound * Able to understand and sign Informed Consent Exclusion Criteria: * Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years * Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate * Subjects with previous bilateral oophorectomy * Any subject known to be pregnant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cancer vs Benign Disease

Trial details

NCT IDNCT00315692

SponsorFujirebio Diagnostics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Ovarian Cancer trials