Blood Test for Ovarian Cancer Associated Auto Antibodies

Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary diagnostic techniques.

Test Description: Blood is collected from patients and serum/plasma is tested for the presence of CAAA on experimental test kit.

Objectives: To assess the effectiveness of the CAAA test.

Target Population:

The study population will include women that have been diagnosed with suspected ovarian cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer but verified by pathology/cytology as non-cancers and a control set of blood samples will be collected from age matched women with no history of cancer.

Structure: Women that will be enrolled for the study will be checked for the presence of CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the physicians in the participating centers for the patient population and to the clinical history for the control population.

Sample Size: The investigators will collect at least 50 patients verified by pathology/cytology and for each patient at least two aged matched healthy controls and two aged matched suspected but verified as non-cancers. Total amount at least 250 samples.

(Multi center study, statistical rationale provided below).

Primary Effectiveness Variables: The effectiveness of the test will be defined by the specificity of the test conditionally that the sensitivity is not lower than a pre-defined level of 95%.

Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.

Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical trials. All data will be stored in a protected internet-based database, and any changes of the data will be traced and recorded.