Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

NCT ID: NCT03404687

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2018-01-01

Brief Summary

The presence of an adnexal mass is a frequent reason for a woman to be referred to a gynaecologist. The discrimination between benign and malignant adnexal masses is central to decisions regarding clinical management and surgical planning in such patients. Patients with malignant tumours should be referred to a gynaecological oncologist, as the quality of cytoreductive surgery and surgical staging/lymph node dissection are important prognostic factors in ovarian cancer. These specialized surgical procedures require the specific skills and experience provided by gynaecologic oncology surgeons. Furthermore, appropriate and timely referral to a gynaecologic oncologist has been proven to increase survival in patients with ovarian cancer.Conversely, patients believed to have a benign mass requiring surgery are able to have this performed by a general gynaecologist. A standardized method for preoperative identification of probable malignant masses would allow optimization of first-line treatment for women with ovarian cancer. A risk of malignancy index would be valuable for the selective referral of relevant patients to specialized oncology centres. Currently, clinical examination, ultrasound assessment, and assays of tumour markers are part of the standard work-up for an adnexal mass. Although none of these indicators alone is very sensitive or specific for detecting malignancy, an index developed by Jacobs et al. incorporates information about the patient's menopausal status and serum Cancer antigen A-125 levels, and ultrasound characteristics of the mass to predict the risk of malignancy with greater sensitivity and specificity than any one factor alone.Some of the potential advantages of risk malignant index include rapid triage of patients through the referral system and fewer operations for benign masses being performed by gynaecologic oncologists.

Conditions

Risk Malignant Index

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with adnexal masses

ultrasound

Intervention Type: RADIATION

for assessment of adnexal masses size and pattern

cancer antigen 125 level

Intervention Type: DIAGNOSTIC_TEST

for prediction of malignancy

Doppler

Intervention Type: RADIATION

for detection of blood flow

Interventions

ultrasound

for assessment of adnexal masses size and pattern

Intervention Type: RADIATION

cancer antigen 125 level

for prediction of malignancy

Intervention Type: DIAGNOSTIC_TEST

Doppler

for detection of blood flow

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age at menarche to 60 years.

2. Presence of ovarian mass clinically by vaginal or bimanual examination.

3. Presence of sonographically diagnosed ovarian mass.

4. Accepting and signing the informed written consent.

Exclusion Criteria

1. Known diagnosis of nature of mass by previous biopsy or ovarian malignancy scheduled for second look operation.

2. Patient unfit for surgery or inoperable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

RMI_ASS

Identifier Type: -

Identifier Source: org_study_id