The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses

• Conditions: Adnexal Mass
• Interventions: Procedure: Excision of adnexal mass through laprotomy

• Registration Number: NCT03442881
• Lead Sponsor: Cairo University

Brief Summary

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

Detailed Description

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Last Update Submitted: 2018-02-16
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. Patients who will undergo surgical intervention . 3. Patients are recruited regardless of age, parity and complaint

Read More

Exclusion Criteria

• Patients treated with conservative management. 2. Patients known to be pregnant.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
benign adnexal mass	Excision of adnexal mass through laprotomy	pathological examination of the specimen after excision reveals benign criteria
Malignant adnexal mass	Excision of adnexal mass through laprotomy	pathological examination of the specimen after excision reveals malignant criteria

Primary Outcome Measures

Name	Time	Method
Nature of the mass	At time of surgery	Benign or malignant criteria of the excised adnexal mass

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt