Clinical Trials

What Is a Clinical Trial?

Clinical trials are research that prospectively assign human subjects to intervention and concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome.

They research studies that involve people and explore whether a medical strategy, treatment, or device is safe and effective. These studies also may show which medical approaches work best for certain illnesses or groups of individuals.

Ovarian cancer clinical trials are designed to test new ways to:

• Treat ovarian cancer
• Detect ovarian cancer early
• Prevent ovarian cancer
• Manage symptoms of illness or side effects from its treatment

What Are The Types Of Clinical Trials?

Ovarian cancer clinical trials are broken down into 4 separate categories. They are as follows:

Prevention — These trials test new interventions that may lower the risk of developing cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past; these trials test interventions that may help prevent the return (recurrence) of the original cancer or reduce the chance of developing a new type of cancer, this is an important distinction for ovarian cancer as it has a significantly high rate of recurrence.

Screening — Used to find new ways to detect cancer, especially in the early stages. The early detection methods used are the ultrasound and CA125.

Diagnostic — New PET imaging modalities for detection of ovarian cancer sites.

Quality of Life & Supportive Care — Explore ways to improve quality of life for cancer patients.

Treatment — These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, and vaccines or other treatments that stimulate a person’s immune system to fight cancer. Combinations of different treatment types may also be tested in these trials.

Who Can Participate in a Clinical Trial?

Clinical trials have standards, also known as eligibility requirements, that determine who can or cannot participate.

The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, the stage of ovarian cancer, previous treatment history, and other medical conditions.

In order to be included in a clinical trial, a person must volunteer to participate, understand what is being tested, and acknowledge the potential risks and benefits associated with participation in the study.

Why Should You Consider a Clinical Trial?

When faced with a diagnosis of ovarian cancer, the goal for many patients is to find the best treatment available. There may be a good standard of care — that is, a treatment plan the medical profession has determined to be effective in the majority of cases — that is appropriate for your specific situation and treatment history. However, sometimes the current standard of care is not effective. Sometimes the standard of care works for a while, but then stops working. Sometimes there is no standard of care for the situation. At these times, participation in a clinical trial may be the best available option. To be eligible for clinical trials, timing is everything. If you begin treatment without considering trials, you may later find you are ineligible for some trials.

The more women who take part in ovarian cancer clinical trials, the faster we can find better ways to treat the disease. Clinical trials are carefully designed research studies that involve patient volunteers. Clinical trials seek to find ways to improve the medical care and treatment available to women with ovarian cancer.

There are clinical trials for women at any point in their experience with ovarian cancer. It is important for each woman to be aware of the possible clinical trial options available to her. Your doctor may discuss clinical trial options or she may not.  Be sure to ask your doctor or Clearity about the possibilities if you are interested.

Clinical trials study new ways to:

• Prevent women who are at high risk for ovarian cancer from developing the disease
• Detect and diagnose ovarian cancer
• Treat ovarian cancer
• Improve the quality of life for women with ovarian cancer both during and after treatment
• Prevent the recurrence of ovarian cancer
• Monitor women for recurrence to detect it early

Clinical Trials Videos for Patients

“Understanding Gynecologic Cancer Clinical Trials” is a useful resource for patients who might be considering a clinical trial. This four-minute animated video explains the main phases of clinical trials, as well as the possible differences between treatment arms.

“Gynecologic Cancer Clinical Trials: What This Means for You,” is a video teaching tool for patients who might be interested in participating in gynecologic cancer clinical trials. This 19-minute program includes interviews with clinical trials patients describing their experiences as well as SGO member experts who debunk some of the misconceptions and myths surrounding clinical trials.

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