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OpenTrials
Completed

NCT Number: NCT03404687

Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Ultrasound

Radiation

for assessment of adnexal masses size and pattern

cancer antigen 125 level

Diagnostic Test

for prediction of malignancy

Doppler

Radiation

for detection of blood flow

Primary outcomes

  1. Number of women has a malignant adnexal mass

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 19, 2018
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.