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To classify adnexal mass pre-operatively as benign and malignant by IOTA ADNEX Model

To evaluate performance of IOTA ADNEX model in discrimination of adnexal masses preoperatively: an ambispective study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048329
Enrollment
100
Registered
2022-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

Interventions

None listed

Sponsors

Prof Anupama Bahadur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All female above 18 years with adnexal mass

Exclusion criteria

Exclusion criteria: 1)Pregnancy 2)Patient is managed conservatively (no surgery) 3)Incomplete ultrasound data not fulfilling IOTA protocols 4)Patients who had undergone any surgery on ovaries previously.

Design outcomes

Primary

MeasureTime frame
To classify adnexal masses according to IOTA ADNEX Model into benign and malignant with histopathology as gold standard.Timepoint: HPE report after surgery, 18 months—

Secondary

MeasureTime frame
To evaluate the predictive performance of IOTA-ADNEX model in different histological types of ovarian malignancy.Timepoint: HPE report after surgery, 18 months;To identify optimal cut-off value for predicting malignant adnexal masses.Timepoint: HPE report after surgery—

Countries

India

Contacts

Public ContactShreya Singhvi

AIIMS Rishikesh

anupama.bahadur@gmail.com9810326959

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026