Clinical trial NCT03404687: Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy
Official title: Comparative Study Between Use of the Risk of Malignancy Index Versus Assiut Scoring Model in Preoperative Prediction of Adnexal Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Malignant Index
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients has any adnexal mass by ultrasound

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.


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.

Primary outcomes:
measure: Number of women has a malignant adnexal mass
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: