IOTA Ultrasound Criteria and Serum CA 125 for Ovarian Malignancy Detection

NCT06977334CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Maharajgunj Medical Campus

Enrollment

64

Start Date

2022-01-01

Completion Date

2022-12-31

Study Type

OBSERVATIONAL

Official Title

Identification of Ovarian Malignancy With Ultrasonography Based Criteria (IOTA) and Serum CA 125

Conditions

Ovarian NeoplasmsOvarian CancerOvarian Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

* Proven cases of ovarian malignancy
* Ovarian mass in pregnancy

Outcome Measures

Primary Outcomes

Sensitivity of IOTA Simple Rules

Proportion of histologically malignant masses correctly identified by IOTA criteria.

Time frame: At surgery/histopathology

Specificity of IOTA Simple Rules

Proportion of histologically malignant masses correctly identified by IOTA criteria.

Time frame: At surgery/histopathology

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

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

Time frame: Preoperative blood draw

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

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

Time frame: Preoperative blood draw

Area Under the ROC Curve for CA 125

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

Time frame: Preoperative blood draw vs histopathology

Locations

Nobel Medical College Teaching Hospital, Biratnagar, Nepal

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.