A blood test to detect tumor cells in women suspected of having ovarian cancer has been fine-tuned and evaluated in a pilot study, and now the Wilmot Cancer Institute expects to launch a larger clinical trial this year to validate the test in 200 local patients.
As part of the study, women with a known lump or mass in the pelvic region who are scheduled for surgery would also submit a blood sample. Investigators will use new technology to search the blood for the presence of ovarian cancer cells. The pilot studies suggested the test can pick up as few as five or 10 cancer cells in the bloodstream in many patients, predicting with some specificity that the pelvic mass is malignant, said Richard Moore, M.D., director of Wilmot’s Gynecologic Oncology program, and director of the Targeted Therapeutics Laboratory for Gynecologic Cancers.
Moore is working in partnership with a United Kingdom-based company, Angle PLC, which developed the test, also known as a “liquid biopsy,” and will be the lead investigator on the larger clinical trial. Moore is a professor of Obstetrics and Gynecology at the University of Rochester Medical Center.
One value of a blood test is simplicity: Getting blood drawn is less invasive than undergoing a surgical biopsy, which is the standard way to diagnose ovarian cancer. Preliminary studies were designed to determine if the blood test could accurately detect cancer in patients who were already known to have cancer (through standard biopsies), or to show no cancer cells present in patients who were already known to be healthy volunteers, Moore said.
The larger study is needed to confirmation the earlier data, which showed the blood test could identify ovarian cancer cells; investigators are preparing a manuscript for publication of that data.
When tumors shed cancer cells into the bloodstream, the result is called “circulating tumor cells.” Scientists will also be able to use the blood tests to search for genetic signatures on the circulating tumor cells that might give clues about ovarian cancer prognosis.
When the larger trial of 200 women begins, all of the study participants will receive the best standard of care from diagnosis through treatment, in addition to the investigative blood test.
If all goes as planned, Moore said, the blood test would be submitted to the U.S. Food and Drug Administration for approval. Eventually, investigators believe the test might also be used as a way to monitor patients who have been treated for ovarian cancer but are at risk for a relapse. The test might also have an application for breast cancer, either to evaluate response to therapy or to detect a relapse before a patient experiences symptoms, he added.
Ovarian cancer symptoms
Ovarian cancer often comes with vague symptoms and, despite the progress in ovarian cancer research, there is still a lack of widely available screening tools. But once a growth is detected, it’s important to act immediately so that doctors can quickly distinguish between an ovarian cyst and cancer. Wilmot also offers several additional clinical trials for ovarian cancer treatment.
Ovarian cancer symptoms that should not be ignored, especially if they persist, include: gas or bloating, pelvic pain or pressure, feeling full quickly after eating, vaginal discharge or abnormal bleeding, urgency to urinate frequently, as well as fatigue, upset stomach, pain during sex, constipation, or menstrual changes.