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Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04473833
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
John R van Nagell, University of Kentucky

Brief Summary:
This is a large, prospective, single-arm cohort study of transvaginal ultrasonographic screening for ovarian cancer in intermediate to high-risk women from Kentucky. Detection of ovarian malignancy often occurs subsequent to the initial transvaginal sonography (TVS) screen; therefore, it is important to offer continued screening to study participants based on our published algorithm. Screening will be available to participants for as long as they elect to receive it. The primary study endpoints are to determine if prospective serial transvaginal ultrasonography can decrease the false-positive (FP) percentage and improve the positive predictive value (PPV) as suggested by retrospective analysis without compromising the detection of true positives or promote the occurrence of false negatives.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Serial Transvaginal Ultrasonography Not Applicable

Detailed Description:

Women from every Kentucky county participate in the Kentucky Ovarian Cancer Screening Program. Screening sites include: Maysville, Prestonsburg, Greenup, Elizabethtown, Somerset, Paducah and Lexington. Offsite participants account for 14% of the screening population with 86% being screened in Lexington. The long-term survival (20 year) of women with screen-detected ovarian cancers is twice that of unscreened women (65% vs 32%). Separation of cases into Type 1 and Type 2 ovarian cancer shows that screening improves the survival of both Type 1 and Type 2 ovarian cancers. Type 1 ovarian carcinomas for the screened and unscreened populations were defined based on these WHO criteria: mucinous carcinomas all grade, clear cell carcinomas all grades, endometrioid carcinomas grades 1 & 2, serous carcinomas grades 1 & 2, and malignant Brenner's tumors all grades. Type 2 ovarian carcinomas for the screened and unscreened populations were defined based on these criteria: undifferentiated carcinomas, endometrioid carcinomas grade 3, serous carcinomas grade 3, and carcinosarcomas.

While long-term 20-year survival of women with Type 1 ovarian cancers detected by screening was significantly better than for unscreened women (81% v 46%, respectively), the survival benefit was even more pronounced for Type 2 ovarian cancers detected by screening of Kentucky women compared to unscreened Kentucky women (55.7% vs. 0.3%, respectively) or unscreened women at UK Hospital (12%). Screen-detected cases of Type 2 invasive ovarian cancers had better survival than unscreened cases when those detected had early- or late-stage disease. However, better survival was achieved when Type 2 ovarian cancers were detected at an early (72%) compared to late-stage (46%). Our data support the effectiveness of the screening protocol at the University of Kentucky, and subsequent treatment in accordance with National Comprehensive Cancer Network guidelines.

The significance of these findings is that our approach has resulted in the detection of both early-stage Type 1 and Type 2 ovarian cancers and these cases have had improved survival when compared to that of unscreened cases, indicating that the screen-detected cases are associated with a potential survival advantage even for aggressive ovarian carcinomas.

The primary objective of this study is to prospectively evaluate the false positive (FP) percentage generated by the ovarian screening algorithm and determine whether serial transvaginal ultrasonography can lower the FP percentage as demonstrated in the retrospective analysis. The aim of serial ultrasonography is to decrease FP percentage to 0.32% (positive predictive value of 24%) without adversely impacting the results for true positives and false negatives. on a "per woman screened basis" since this corresponds to a minimally acceptable positive predictive value of 24% or higher. This assumes an average of three screening years for each new woman entering the program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
Actual Study Start Date : December 19, 1988
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Participants in the Kentucky Ovarian Cancer Screening Program
Participants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening.
Procedure: Serial Transvaginal Ultrasonography
Participants will undergo transvaginal ultrasonography (TVS) to detect ovarian cancer as part of the Kentucky Ovarian Cancer Screening Program. Those with normal findings will repeat the TVS in one year. Those with abnormal results will repeat the screening in 4-6 weeks.

Primary Outcome Measures :
  1. False-positive (FP) percentage [ Time Frame: approximately 3 years ]
    Measure the false-positive (FP) rate generated by the ovarian screening algorithm.

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women over the age of 50 years;
  • women with a documented family history of ovarian cancer over the age of 24 years;
  • women over the age of 24 years with a personal history of breast cancer
  • ECOG performance status of 0 to 2.34
  • Subjects having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study and have at least one ovary.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Women who are referred with pelvic symptoms, a known pelvic mass or a history of prior radiation.
  • Individuals that cannot safely receive transvaginal ultrasound due to vaginal size, vaginal infections, lack of bowel or bladder control or inability to physically place their body in position to receive transvaginal ultrasound
  • Prisoners
  • Pregnant women
  • Women with a prior history of ovarian cancer
  • Exclusions will apply to anyone who presents with factors or issues that prevent them from understanding the screening research procedures or completing the informed consent component or personal information needed for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04473833

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Contact: Tina Payne 859-323-4687

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United States, Kentucky
Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: John R Van Nagell         
Principal Investigator: John Villano, MD         
Sponsors and Collaborators
John R van Nagell
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Principal Investigator: John R Van Nagell University of Kentucky
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Responsible Party: John R van Nagell, Professor, University of Kentucky Identifier: NCT04473833    
Other Study ID Numbers: MCC-88-GYN-13
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by John R van Nagell, University of Kentucky:
transvaginal ultrasonography
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type