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Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

Comparative Study Between Use of the Risk of Malignancy Index Versus Assiut Scoring Model in Preoperative Prediction of Adnexal Malignancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03404687
Enrollment
250
Registered
2018-01-19
Start date
2016-01-01
Completion date
2018-01-01
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Malignant Index

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.

Interventions

RADIATIONultrasound

for assessment of adnexal masses size and pattern

DIAGNOSTIC_TESTcancer antigen 125 level

for prediction of malignancy

RADIATIONDoppler

for detection of blood flow

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of women has a malignant adnexal mass7 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026