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

Cairo University (CU)

Status: Unknown

Conditions: Adnexal Mass

Treatments: Procedure: Excision of adnexal mass through laprotomy

Study type: Observational

Funder types: Other

Identifiers

NCT03442881

28

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: Female

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

80 participants in 2 patient groups

benign adnexal mass

Description:

pathological examination of the specimen after excision reveals benign criteria

Treatment:

Procedure: Excision of adnexal mass through laprotomy

Malignant adnexal mass

Description:

pathological examination of the specimen after excision reveals malignant criteria

Treatment:

Procedure: Excision of adnexal mass through laprotomy