An ovarian cancer research trial to evaluate the effectiveness of a new blood test for the early detection of ovarian cancer.
The OVERT study is collecting blood samples to evaluate a new method of detecting ovarian cancer at the earliest stages.
Currently, there is no test available to accurately determine the likelihood of ovarian cancer in women having symptoms of the disease. Unfortunately, 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.
Early stages of ovarian cancer have been linked to a variety of symptoms, which indicates to physicians that a patient might need further examination.
AOA Dx has identified a selection of blood markers that have been linked to ovarian cancer. By collecting the blood of women with signs and symptoms of ovarian cancer, AOA Dx can evaluate the accuracy of the markers for the early detection of the disease.
Early detection of ovarian cancer is key to increasing survival rates. Currently, women that are diagnosed with late-stage ovarian cancer have a 5-year survival rate as low as 28%. However, women diagnosed at the early stages have a 5-year survival rate as high as 90%.
Developing a simple blood test that can accurately diagnose women with symptoms at the earliest stages could significantly improve outcomes.
Thousands of woman aged 18 years and older with symptoms of ovarian cancer will take part in the OVERT study. Participation in this study will contribute to scientific research that could improve ovarian cancer diagnosis and transform early detection for women.
Blood is collected through a routine blood draw and tested for markers linked to ovarian cancer. If the markers are present in a patient’s blood it is likely that the patient has ovarian cancer. The test provides a much less invasive way to detect ovarian cancer. Today, the current diagnostic method involves an invasive biopsy and the removal of one ovary and one fallopian tube.
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 be either be referred to a specialist or more likely return to your physician for up to three follow up visits at 6, 9 and 12 months after your first visit. Each follow up visit 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 Dx is a team of women’s health specialists that aims to bring to market innovative, impactful, and cost-effective medical technologies. AOA Dx’s goal is to revolutionize the early diagnosis of cancer 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
