Risk Malignant Index Clinical Trial
Official title:
Comparative Study Between Use of the Risk of Malignancy Index Versus Assiut Scoring Model in Preoperative Prediction of Adnexal Malignancy
| Verified date | January 2018 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | January 1, 2018 |
| Est. primary completion date | December 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Women Health Hospital - Assiut university | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of women has a malignant adnexal mass | 7 days |