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Could a vaginal fluid test spot ovarian cancer earlier?

NCT ID NCT02109367

Diagnosis Sponsor: Southern Illinois University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether fluid collected from behind the vagina (culdocentesis) can help diagnose ovarian cancer. Researchers measured tumor markers CA-125 and HE4 in the fluid of 52 women scheduled for surgery. They also checked a urine sample for estrogen ratios. The goal was to see if these markers match the final diagnosis, possibly leading to a simpler, low-risk diagnostic tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

52 people

The number who actually took part.

Started

Feb 2014

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult women with a suspicious adnexal mass that could possibly be ovarian cancer who are scheduled for oophorectomy, bilateral salpingo-oophorectomy (BSO), hysterectomy via laparotomy or laparoscopy, hysterectomy/BSO, staging and/or debulking.

Ages

30 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Patients age ≥ 30. * Adnexal mass or suspected ovarian carcinoma. * Patient has been scheduled for oophorectomy, bilateral salpingo- oophorectomy (BSO), hysterectomy, hysterectomy/BSO, staging or debulking. * Willingness to sign an Informed Consent document. Exclusion criteria: * Patients previously diagnosed with a malignancy within the pelvis or abdomen. * Patients in which culdocentesis is technically unfeasible due to previous surgery (extensive pelvic floor repair/colpocleisis) or other anatomic abnormalities that make the cul-de-sac inaccessible.

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Conditions

The condition(s) this trial relates to.

ovarian cancer ovarian carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

Contacts and locations

Locations

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9640, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.