Researchers from Penn State College of Medicine are participating in a study that will evaluate whether a blood test can be used to determine if a person has endometriosis – a painful gynecologic health condition. They said if the test’s accuracy is confirmed, it could shorten the time to diagnosis and treatment and may prevent years of uncomfortable symptoms, disease progression and high health care costs.
Endometriosis is a disease in which tissue from the uterus – the organ in which a baby develops before birth – can be found in other areas of the body. It can cause pain, bleeding and scars resulting in symptoms including pain during periods and sex, chronic pelvic pain, heavy or irregular bleeding and infertility. The disease affects approximately 10% of women of reproductive age worldwide.
Dr. Timothy Deimling, associate professor and vice chair for research in the Department of Obstetrics and Gynecology, said that symptoms of endometriosis are often confused with other gynecological or digestive disorders, which can make it difficult to diagnose. The only current method for confirming endometriosis is surgery, which can take a while since gynecologists carefully consider symptoms before scheduling invasive procedures.
“A noninvasive test could help us get patients the treatment they need sooner so we can improve their quality of life,” Deimling said. “Delayed diagnosis can cause reproductive or other complications as a result of advanced disease progression.”
Deimling will lead Penn State Health Milton S. Hershey Medical Center’s involvement in the multi-center study, which will evaluate if DotEndo, a noninvasive test for endometriosis developed by DotLab, a health care technology company, can be used to help gynecologists confirm active endometriosis. Diagnosis is confirmed by testing for the presence and number of specific tiny strands of genetic material called micro-ribonucleic acid (mRNA) in a patient sample.
The EMPOWER study is a prospective, observational study that will enroll approximately 750 women of reproductive potential aged 18 to 49 who have been referred to undergo surgeries or other procedures for suspected endometriosis and other benign gynecological indications. The researchers will collect blood and saliva samples and the performance of DotLab’s test for the diagnosis of endometriosis will be compared to the standard of care, visual assessment at the time of surgery. In accordance with standard clinical research protocol, eligible patients will provide informed consent to participate in this trial. Patient participation is optional.
“We are excited to offer our patients the opportunity to participate in this study,” said Dr. Richard Legro, professor and chair of Obstetrics and Gynecology. “The expertise and reputation of the providers in our Center for Endometriosis and Female Pelvic Pain allow us the ability to participate in this important study.”
Learn more about the EMPOWER study.
For more information about clinical trials for endometriosis and other women’s health conditions, visit Studyfinder.
This research is being conducted using funds from Dot Laboratories, Inc. This research will evaluate DotEndo, a noninvasive test for endometriosis, developed and provided by the aforementioned sponsor. The Pennsylvania State University does not endorse, promote or recommend DotEndo or any other commercial product or service. The views and opinions expressed by the researchers do not necessarily reflect those of The Pennsylvania State University, and any use of the names and logos of The Pennsylvania State University or its personnel without prior written consent is prohibited.
About Penn State College of Medicine
Located on the campus of Penn State Health Milton S. Hershey Medical Center in Hershey, Pa., Penn State College of Medicine boasts a portfolio of more than $100 million in funded research. Projects range from development of artificial organs and advanced diagnostics to groundbreaking cancer treatments and understanding the fundamental causes of disease. Enrolling its first students in 1967, the College of Medicine has more than 1,700 students and trainees in medicine, nursing, the health professions and biomedical research on its two campuses.
