Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

NCT03404687 | Completed

• 1 other identifier: RMI_ASS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of women has a malignant adnexal mass

  7 days

Study Arms (1)

Patients with adnexal masses

Radiation: ultrasound; Diagnostic Test: cancer antigen 125 level; Radiation: Doppler

Interventions

ultrasound RADIATION

for assessment of adnexal masses size and pattern

Patients with adnexal masses

cancer antigen 125 level DIAGNOSTIC_TEST

for prediction of malignancy

Patients with adnexal masses

Doppler RADIATION

for detection of blood flow

Patients with adnexal masses

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients has any adnexal mass by ultrasound

You may qualify if:

• Age at menarche to 60 years.
• Presence of ovarian mass clinically by vaginal or bimanual examination.
• Presence of sonographically diagnosed ovarian mass.
• Accepting and signing the informed written consent.

You may not qualify if:

• Known diagnosis of nature of mass by previous biopsy or ovarian malignancy scheduled for second look operation.
• Patient unfit for surgery or inoperable.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 19, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

EG (1)