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Suspicious ovarian mass is imprint cytology equally good as frozen section biopsy done during surgery.

Assessment of Concordance between imprint cytology with final histopathology for intraoperative decision making in suspicious adnexal masses - A Phase II Single Arm Study. - IMFHA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084487
Enrollment
108
Registered
2025-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: D10-D36- Benign neoplasms, except benign neuroendocrine tumors Health Condition 2: C569- Malignant neoplasm of unspecifiedovary Health Condition 3: D495- Neoplasm of unspecified behavior of other genitourinary organs

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients with suspicious adnexal masses 2. Fitness for surgery 3. Signed, written informed consent 4. Age:18 years and above

Exclusion criteria

Exclusion criteria: 1. Suspected advanced stage/metastatic disease 2. Physical comorbidities or concurrent conditions and anaesthetic considerations posing very high risk or unfit for surgery. 3. Pregnant women

Design outcomes

Primary

MeasureTime frame
The primary outcome is concordance of the IC finding with Frozen section i.e. where categorisation as benign, borderline or malignant is the same by both methods.Timepoint: 3 years—

Secondary

MeasureTime frame
1. Concordance of IC & FS with final HPR (endpoint concordance rates) 2. Sensitivity,specificity,positive predictive values & negative predictive values of ICTimepoint: 3 years—

Countries

India

Contacts

Public ContactDr Biswajit Dash

Tata Memorial Centre

dbiswajit_dr@yahoo.com8895331662

Outcome results

None listed

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