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Transvaginal Ultrasound Screening for Ovarian Cancer

N/A

Recruiting

Led By John R Van Nagell

Research Sponsored by John R van Nagell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women over the age of 50 years

ECOG performance status of 0 to 2.34

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Study Summary

This trial is studying whether transvaginal ultrasonographic screening can decrease the false-positive percentage and improve the positive predictive value for ovarian cancer in intermediate to high-risk women from Kentucky.

Who is the study for?

This trial is for women over 50, or those with a family history of ovarian cancer over 24 years old, and women over 24 with a personal history of breast cancer. Participants must have at least one ovary, be able to consent, and have an ECOG performance status up to 2.34. It excludes symptomatic individuals, prisoners, pregnant women, those unable to understand the study or give informed consent.Check my eligibility

What is being tested?

The study tests if serial transvaginal ultrasonography can effectively screen for ovarian cancer in high-risk women by reducing false positives and increasing positive predictive value without missing true cases or creating false negatives. Women will receive ongoing screening based on a specific algorithm.See study design

What are the potential side effects?

Transvaginal ultrasonography is generally safe but may cause discomfort during the procedure. There's also a small risk of infection following the ultrasound exam.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged over 50 years.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a woman over 24 with a history of breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

False-positive (FP) percentage

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants in the Kentucky Ovarian Cancer Screening ProgramExperimental Treatment1 Intervention

Participants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

John R van NagellLead Sponsor

John R Van NagellPrincipal InvestigatorUniversity of Kentucky

Media Library

Serial Transvaginal Ultrasonography Clinical Trial Eligibility Overview. Trial Name: NCT04473833 — N/A

Ovarian Cancer Research Study Groups: Participants in the Kentucky Ovarian Cancer Screening Program

Ovarian Cancer Clinical Trial 2023: Serial Transvaginal Ultrasonography Highlights & Side Effects. Trial Name: NCT04473833 — N/A

Serial Transvaginal Ultrasonography 2023 Treatment Timeline for Medical Study. Trial Name: NCT04473833 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to enroll in this research initiative?

"Affirmative. According to the clinicaltrials.gov website, recruitment for this research is currently in progress and has been since December 19th 1988 (with a recent amendment on November 1st 2022). 58000 individuals are being sought after at one medical facility."

Answered by AI

What is the upper limit of participation for this experiment?

"Correct. According to the clinicaltrials.gov records, this medical research is actively seeking applicants since it was first posted on December 19th 1988 and recently modified on November 1st 2022. 58000 participants must be recruited across one site for this trial to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

John R van Nagell 1988. "Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04473833.