Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

NCT01477788 | Withdrawn

• 1 other identifier: EMC-0083-09
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).

Conditions

Ovarian Neoplasm

Keywords

pelvic mass; ovarian mass; ultrasound; serum markers; ovarian malignancy

Outcome Measures

Primary Outcomes (1)

• The risk of malignancy in the presence of pelvic mass demonstrated by sonography.

  Using a combination of the results of US examination, patient's history and serum markers to predict the risk of malignancy in women with pelvic mass demonstrated by sonography.

  Up to 2 months after recruiting and examining the last participant of the study

Secondary Outcomes (3)

• number and kind of operative complications

  within one month after operation

• Reasons for intervention

  within one month after operation

• operative finding and histologic results

  within one month after operation

Study Arms (1)

women, sonographic ovarian mass

women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass

Eligibility Criteria

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

Study Population

Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass

You may qualify if:

• Patients referred with sonographic diagnosis of pelvic mass

You may not qualify if:

• Pregnant women
• Known gynecologic malignancy

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (1)

Sonographic unit, Department of Ob/Gyn, Haemek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• yfat kadan, MD

  Department of Ob/Gyn, Haemek medical center, Afula Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: November 23, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 18, 2015

Record last verified: 2011-11

Locations

IL (1)