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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03442881
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adnexal Mass	Procedure: Excision of adnexal mass through laprotomy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
benign adnexal mass pathological examination of the specimen after excision reveals benign criteria	Procedure: Excision of adnexal mass through laprotomy; Through laparotomy incision, the adnexal mass will be excised
Malignant adnexal mass pathological examination of the specimen after excision reveals malignant criteria	Procedure: Excision of adnexal mass through laprotomy; Through laparotomy incision, the adnexal mass will be excised

Outcome Measures

Primary Outcome Measures

1. Nature of the mass [At time of surgery]

   Benign or malignant criteria of the excised adnexal mass

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12111

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Ahmed Maged, MD, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Maged, professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03442881
• Other Study ID Numbers: 28
• First Posted: Feb 22, 2018
• Last Update Posted: Feb 22, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Neoplasms

Study Results

No Results Posted as of Feb 22, 2018