IOTA Ultrasound Criteria and Serum CA 125 for Ovarian Malignancy Detection

NCT06977334 | Completed

• 1 other identifier: IRC-NMCTH-08/2021
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional analytic study assessed the diagnostic accuracy of IOTA Simple Rules versus serum CA 125 in women with adnexal masses undergoing surgery. Eighty-two percent of tumors were classifiable by IOTA criteria; CA 125 cut-offs of 35, 70, and 105 U/mL were evaluated against histopathology gold standard.

Conditions

Ovarian Neoplasms; Ovarian Cancer; Ovarian Carcinoma

Keywords

IOTA; CA 125; Ultrasonography; Ovarian malignancy

Outcome Measures

Primary Outcomes (5)

• Sensitivity of IOTA Simple Rules

  Proportion of histologically malignant masses correctly identified by IOTA criteria.

  At surgery/histopathology

• Specificity of IOTA Simple Rules

  Proportion of histologically malignant masses correctly identified by IOTA criteria.

  At surgery/histopathology

• Sensitivity of Serum CA 125 (cut-off 35 U/mL)

  Proportion of malignant tumors with CA 125 \>35 U/mL.

  Preoperative blood draw

• Specificity of Serum CA 125 (cut-off 35 U/mL)

  Proportion of benign tumors with CA 125 ≤35 U/mL.

  Preoperative blood draw

• Area Under the ROC Curve for CA 125

  Discriminatory performance of CA 125 at multiple cut-off points.

  Preoperative blood draw vs histopathology

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient assigned for surgery due to an ovarian tumor in the Department of Obstetrics and Gynecology, Nobel Medical College Teaching Hospital (NOMCTH), Kanchanbari 5, Biratnagar

You may qualify if:

• All age groups and parity with ovarian mass admitted for scheduled surgery.

You may not qualify if:

• Proven cases of ovarian malignancy
• Ovarian mass in pregnancy

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

Nobel Medical College Teaching Hospital

Biratnagar, Koshi, 56700, Nepal

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Chandrika Dangol, MD

  Nobel Medical College Teaching Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS Doctor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

NE (1)