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Clinical Trials/CTRI/2024/01/062051
CTRI/2024/01/062051Active, not recruitingNot Applicable

ORADS in evaluation of adnexal masses

Dr Ayushi Raj1 site in 1 country324 target enrollmentStarted: February 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
324
Locations
1
Primary Endpoint
Accuracy of ORADS in differentiating benign and malignant adnexal masses

Study Overview

Brief Summary

The study included 150 women with adnexal lesion who underwent surgical intervention. The ultrasound findings were recorded as per O’RADS classification and O’RADS categories were tested for accuracy against histopathology.

·       The study cohort had women aged 12- 72years with the mean age of 35.89 years.

·       63 (42%) of women had normal BMI and 87 (58%) women had BMI >25 kg/m².

·       There were 83 (55.3%) participants who were nulliparous and 67 (44.7%) were multiparous.

·       Nearly one-third {43 (28.7%)} of the participants had history of infertility. 28 (18.7%) women were known case of endometriosis and 22 (14.7%) were postmenopausal.

·       There were 50 (33.3%) women who were co morbid and 5 (3.3%) had family history of cancer.

·       Out of 150, 131 (87.3%) were non-malignant and 19 were malignant (12.7%) which included 6 borderline tumours.

·       O’RADS category 2 (benign) had 74 cases and 100% were benign, category 3 (low risk) had 32 cases in which only 1 (3.1%) was malignant, category 4 (intermediate risk) had 38 cases in which 12 (31.6%) were malignant and category 5 had 6 cases and 100% were malignant.

·       Among the ultrasound parameters, features significantly associated with malignancy were colour score, ascites, solid areas, inner margins and number of papillary projections.

·       O’RADS 4 had the highest false positive cases among all categories. Ultrasound parameters resulting in maximum false positives were number of locule, solid areas and number of papillary projections.

·       Taking O’RADS 4 as the appropriate cutoff for malignancy, the diagnostic accuracy of O’RADS was 82.7% with sensitivity of 94.7% and specificity of 80.9%.

·       Statistically significant relationship was seen between O’RADS risk of malignancy and final impression. (p <0.001).

Study Design

Study Type
Observational

Eligibility Criteria

Ages
12.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • (1) presence of at least one adnexal lesion detected by transvaginal or transabdominal ultrasonography like: Simple ovarian cyst, ectopic, ovarian tumors, tubal or broad ligament neoplasms etc.
  • (2) lesion removed surgically and evaluated histopathologically.
  • (3) time interval between ultrasound detection and surgery not exceeding 30 days.

Exclusion Criteria

  • (1)women with adnexal lesion not removed surgically or not evaluated histopathologically.
  • (2) women on conservative management and follow up.

Outcomes

Primary Outcomes

Accuracy of ORADS in differentiating benign and malignant adnexal masses

Time Frame: 1 year 4 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Ayushi Raj
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Ayushi Raj

KMC, Manipal

Study Sites (1)

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