A trial to evaluate the effectiveness of a new experimental blood test for the early detection of ovarian cancer.
The OVERT study is collecting blood samples to evaluate a new experimental method to detect the possibility of ovarian cancer at the earliest stages.
Currently, there is no test available to accurately determine the likelihood of ovarian cancer in women having symptoms. The average time to diagnosis in the United States is 9 months and ovarian cancer progresses quickly. Reducing the time it takes to detect ovarian cancer with a simple blood test could enable faster specialist care and improved outcomes.
Symptoms of ovarian cancer are vague and are often ignored; research shows women have symptoms early in the course of disease. It is important to take women’s symptoms seriously and reduce the likelihood that they are due to ovarian cancer, which in the early stages is a highly treatable disease. Symptoms include:
AOA Dx has identified a selection of blood markers that have been linked to Ovarian Cancer. By collecting the blood of women with vague gynecologic and gastrointestinal signs and symptoms, AOA Dx can study the accuracy of the test in evaluating the likelihood of disease and help women and their providers more quickly diagnosis the cause of their pain.
Blood is collected through a routine blood draw and tested for markers linked to ovarian cancer. It suggests a likelihood that the disease is present, easing anxieties about vague symptoms and moving women faster towards understanding what is causing their symptoms.
Early detection of ovarian cancer is key to saving lives. Developing a simple blood test that can accurately diagnose women with symptoms at the earliest stages could significantly improve outcomes. Up to 5,000 women aged 22 years and older with the listed symptoms will take part in the OVERT study. Participation in this study will contribute to scientific research that could transform early detection of disease for women.
If you are eligible to participate in the study, you will complete a simple symptom questionnaire and your physician will conduct a physical examination, review your clinical history and symptoms, collect a blood sample, and perform a transvaginal ultrasound (TVU). Depending on your physician’s findings you will either be referred to a specialist or more likely require follow up visits at 6 and 12 months after your initial visit. The 6 month follow up visit will be a telephone consultation and the 12 month follow up visit will be a telephone consultation or a possible in person visit that will include a physician examination, review of your symptoms, a blood sample collection, and transvaginal ultrasound. The information collected will enable physicians to assess the accuracy of the blood test.
The study is sponsored and funded by AOA Dx Inc, headquartered in Boston, MA. AOA is a team of women’s health specialists that aims to bring to market innovative, impactful, and cost‐effective medical technologies. AOA’s goal is to revolutionize the early diagnosis of disease by identifying and developing new biomarkers for detection which will aid physicians and improve outcomes for women.
Protocol ID: AOA-PRT-0001
Protocol Title: Collection Banking of Blood Samples for the Study of Female Gynecological Diseases