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

NCT03442881 | Unknown DMC

• 1 other identifier: 28
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Adnexal Mass

Outcome Measures

Primary Outcomes (1)

• Nature of the mass

  Benign or malignant criteria of the excised adnexal mass

  At time of surgery

Study Arms (2)

benign adnexal mass

pathological examination of the specimen after excision reveals benign criteria

Procedure: Excision of adnexal mass through laprotomy

Malignant adnexal mass

pathological examination of the specimen after excision reveals malignant criteria

Procedure: Excision of adnexal mass through laprotomy

Interventions

Excision of adnexal mass through laprotomy PROCEDURE

Through laparotomy incision, the adnexal mass will be excised

Malignant adnexal mass; benign adnexal mass

Eligibility Criteria

• Age: 15 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included 80 patients who had a preliminary diagnosis of adnexal mass clinically and/or sonographically

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Study Officials

• Ahmed Maged, MD

  professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Karim Salama, MSc

CONTACT

ksalama_86@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

EG (1)