The OVERT Clinical Study

A study to evaluate the effectiveness of a new experimental blood test for the early detection of ovarian cancer.

Finding a way to find ovarian cancer earlier often means it can be successfully treated.

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.

Do you qualify?

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.

The OVERT study is seeking to find women that have one or multiple of the following symptoms:

1

Unintentional weight loss

2

Vaginal bleeding (post-menopause)

3

Feeling full after eating a few bites

4

Persistent bloating or abdominal distention

5

Been told you have a lump (mass) on the tissue near your uterus

What is the purpose of the Study?

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.

How does the test work?

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.

Why does participation matter?

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.

What does the study involve?

If you are eligible to participate in the study 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 transvaginal ultrasound. The information collected will enable physicians to assess the accuracy of the blood test.

Study Requirements

To be part of the study you must meet the following requirements:

1

You must be biologically female and at least 22 years old

2

You must have at least one ovary and/or fallopian tube.

3

You must present to your physician with suspicion, signs, or symptoms suggestive of ovarian cancer, which will be confirmed using a symptom index.

If you fit into one of the following criteria you will not be able to participate in the study:

1

If you are pregnant (self-reported)

2

You have received a previous diagnosis of any cancer (other than non-melanoma skin cancer)

3

You are currently having chemotherapy or radiation treatment

Who is sponsoring the study?

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.

For more information on how to enroll at one of our sites, please reach out to using the form below

Inquire about the study

Protocol ID: AOA-PRT-0001

Protocol Title: Collection Banking of Blood Samples for the Study of Female Gynecological Diseases