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

Adnexal Mass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03442881
• Other study ID #: 28
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2018
• Last updated: February 16, 2018
• Start date: February 2018
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Mass
• Ovarian Neoplasms

Intervention

Procedure:
• Excision of adnexal mass through laprotomy
Through laparotomy incision, the adnexal mass will be excised

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature of the mass	Benign or malignant criteria of the excised adnexal mass	At time of surgery