What is an ovarian cancer clinical trial?
A clinical trial is a study involving people that is designed to answer a specific health question. According to the National Cancer Institute, cancer clinical trials can study prevention, screening, diagnosis, treatment, supportive care, and quality of life.
Treatment trials may test a new medicine or a new combination of treatments. They may also study new ways to use surgery, radiation therapy, or existing treatments.
Not every clinical trial involves a novel cancer treatment. Some trials study ways to detect cancer earlier, reduce cancer risk, manage side effects, or improve life during and after treatment.
Each trial follows a detailed plan called a protocol. The protocol explains the purpose of the study, who can participate, what participants will receive, which tests are required, and how safety will be monitored. The National Cancer Institute explains what patients can expect during a clinical trial.
Who can participate in a clinical trial?
Every clinical trial has specific rules about who can participate. These are called eligibility criteria.
Eligibility may depend on factors such as:
- Age
- Ovarian cancer type or subtype
- Cancer stage
- Previous treatments
- How the cancer has responded to treatment
- Genetic or tumor biomarker results
- Overall health
- Other medical conditions
- Results from blood tests or other testing
These requirements help protect participants and allow researchers to answer the study question accurately.
Meeting some of the eligibility criteria does not guarantee enrollment. The study team will review your medical information and may perform additional tests before confirming whether you can join.
You can learn more about eligibility and enrollment through the National Cancer Institute’s guide to what to expect during a clinical trial.
When should I consider a clinical trial?
Depending on the study, a clinical trial may be considered:
- Before your first ovarian cancer treatment
- As part of an initial treatment plan
- During maintenance treatment
- If ovarian cancer returns
- When considering another line of treatment
- During follow-up or survivorship
- When managing treatment side effects or quality-of-life concerns
Prevention and screening trials may also involve people who do not have ovarian cancer.
Ask your gynecologic oncologist about clinical trials whenever you are discussing treatment options or a change in your treatment plan. Trial eligibility can depend on treatments you have already received, so discussing clinical trials early may help you understand all available options.
🎥 Watch: Clinical trials for ovarian cancer: Hope, options, and survivor perspective
In this episode of Teal Talk, gynecologic oncologist Dr. Debra Richardson and ovarian cancer advocate Rhonda Reeve discuss how clinical trials can expand treatment options and what patients should know when considering participation.
Read the full article here.
What types of clinical trials are there?
Clinical trials do more than test new cancer treatments. The National Cancer Institute describes several types of cancer clinical research, including studies focused on prevention, screening, diagnosis, treatment, and supportive care.
Prevention trials
Prevention trials study ways to reduce the chance of developing cancer or prevent cancer from returning.
These studies may involve people with an increased risk of cancer, people who previously had cancer, or other groups depending on the study.
Prevention trials can evaluate medicines, vaccines, lifestyle approaches, or other strategies.
Screening trials
Screening trials study new ways to find cancer before symptoms develop.
For ovarian cancer, these studies are especially important because there is currently no reliable routine screening test for people without symptoms.
Participating in a screening trial does not mean the method being studied has already been proven to detect ovarian cancer effectively.
Diagnostic trials
Diagnostic trials study new or improved ways to identify a disease or better understand abnormal findings.
These studies may evaluate blood tests, imaging, tissue testing, biomarkers, or other diagnostic approaches.
Treatment trials
Treatment trials involve people who have cancer. They study new treatments or new ways of using existing treatments.
A treatment trial might study:
- A new medicine
- A new combination of medicines
- A targeted therapy
- Immunotherapy
- A new surgical approach
- Radiation therapy
- A different dose or treatment schedule
- A treatment chosen using a genetic or tumor biomarker
The National Cancer Institute provides more information about cancer treatment trials and how they are designed to evaluate new approaches to care.
Survivorship, supportive care, and quality-of-life trials
These trials look for ways to improve health and quality of life during or after cancer treatment.
They may study approaches for managing:
- Fatigue
- Neuropathy
- Pain
- Nutrition
- Exercise
- Emotional health
- Sexual health
- Treatment side effects
- Long-term effects of cancer treatment
Some supportive care studies may use telehealth, online surveys, or other approaches that require fewer in-person visits. Learn more about supportive care and quality-of-life clinical trials from the National Cancer Institute.
What are the phases of clinical trials?
Treatment trials that study new medicines or other interventions are often conducted in phases. Each phase is designed to answer different questions.
Not every clinical trial uses this phase structure. Screening, diagnostic, prevention, and quality-of-life studies may be designed differently.
The National Cancer Institute explains how clinical trial phases work and what researchers are trying to learn at each stage.
Phase I clinical trials
Phase I trials focus primarily on safety.
Researchers study questions such as:
- What dose can be given safely?
- What side effects may occur?
- How does the treatment affect the body?
These studies usually involve a smaller number of participants.
Phase II clinical trials
Phase II trials look more closely at whether a treatment appears to work against a particular cancer.
Researchers continue monitoring safety and side effects.
Phase III clinical trials
Phase III trials generally compare a new treatment with the current standard treatment.
Participants may be assigned by chance to different treatment groups. This process is called randomization and helps researchers make fair comparisons between treatments.
Phase IV clinical trials
Phase IV studies take place after a treatment has been approved by the U.S. Food and Drug Administration.
They provide additional information about long-term safety, effectiveness, and how the treatment performs when used by larger and more diverse groups of people.
What happens when you join a clinical trial?
Every clinical trial is different, but most follow a similar process before, during, and after enrollment. The National Cancer Institute provides a detailed overview of what to expect during a clinical trial.
1. Learn about the trial
You may hear about a clinical trial from your health care team or find one through a clinical trial search.
The research team can explain the purpose of the trial and what participation may involve.
2. Pre-screening
A study coordinator or research team member may review basic information about your diagnosis and health.
This helps determine whether you might meet the trial’s eligibility requirements.
3. Informed consent
If the trial may be a match, the study team will explain the trial in more detail.
You will learn about the study treatment or intervention, possible risks and benefits, required visits, alternatives, costs, and your rights before deciding whether to participate.
4. Screening
Additional medical records, blood tests, imaging, or other testing may be needed to confirm eligibility.
Not everyone who begins screening will qualify for the study.
5. Enrollment and participation
If you qualify and choose to participate, the study team will provide a schedule for treatment, tests, visits, and other procedures.
Your health will be monitored throughout the trial.
6. Follow-up
Participation may end when the study is completed, your part of the study is finished, your care team recommends stopping, or you choose to leave.
The study team can explain what follow-up is needed and how your care will continue after participation ends.
How are clinical trial participants protected?
Clinical trials include safeguards designed to protect the rights and safety of participants.
Before a study begins, its protocol is reviewed by an Institutional Review Board, or IRB. The IRB helps make sure participant rights and welfare are protected.
Safety is also monitored while the trial is underway. The National Cancer Institute explains the safeguards used to protect clinical trial participants.
What is informed consent?
Informed consent is the process of learning about a clinical trial before deciding whether to participate.
The study team should explain:
- Why the trial is being done
- What will happen during the study
- Which treatments or procedures are experimental
- Known and possible risks
- Possible benefits
- Other treatment options
- How long participation may last
- Costs that may apply
- Who to contact with questions
- Your rights as a participant
The information should be provided in language you can understand. The U.S. Food and Drug Administration provides additional information about informed consent and protections for research participants.
Signing an informed consent form does not mean you have to stay in the trial. You can ask questions throughout the study and can choose to leave at any time.
Informed consent also continues after enrollment. If important new information becomes available that could affect your decision to participate, the study team should discuss it with you.
What are the possible benefits and risks of a clinical trial?
Every clinical trial is different. The possible benefits and risks depend on the study.
Possible benefits
Possible benefits may include:
- Access to a treatment being studied that is not otherwise available
- Additional monitoring by a research team
- An opportunity to receive a treatment that may eventually become part of standard care
- Helping health care professionals learn information that may benefit people in the future
Possible risks
Possible risks may include:
- The study treatment may not work
- It may not work better than standard treatment
- Side effects may be unexpected or more severe
- More tests or appointments may be required
- Participation may require additional time or travel
- You may have out-of-pocket expenses
A clinical trial cannot guarantee that the treatment being studied will help you.
The National Cancer Institute provides more information about potential benefits and risks of cancer treatment trials. Your care team and the clinical trial team can also help you compare the study with your other treatment options.
Who pays for a clinical trial?
The costs of joining a clinical trial vary by study.
There are generally two types of costs to consider.
Research costs
Research costs are expenses directly related to conducting the study.
These may include the treatment being studied or tests that are performed only for research purposes. These costs are often paid by the clinical trial sponsor.
Routine patient care costs
These are costs you might have even if you were not participating in a clinical trial.
Examples may include:
- Doctor visits
- Hospital care
- Standard cancer treatment
- Laboratory tests
- Imaging
- Treatment for symptoms or side effects
Health insurance often covers routine patient care costs, but coverage can vary.
You may also need to consider expenses such as travel, lodging, parking, meals, or child or elder care.
Some trials or support organizations may help with these costs, while others may not.
Before enrolling, ask the study coordinator exactly which costs the study will cover. You may also want to speak with your insurance company or a financial counselor.
The National Cancer Institute provides additional information about paying for clinical trials.
How do I find an ovarian cancer clinical trial?
Start by talking with your gynecologic oncologist or another member of your health care team.
Your doctor may know about trials offered at your treatment center or may help identify studies at other locations.
Before searching, it can help to have information about:
- Your exact ovarian cancer type and subtype
- Cancer stage
- Previous treatments
- Current treatment
- Genetic testing results
- Tumor biomarker results
- Other important medical conditionsYou can also search for clinical trials yourself.
National Cancer Institute Clinical Trials Search
The National Cancer Institute Clinical Trials Search can help you find cancer clinical trials based on factors such as cancer type, age, and location.
Search NCI Cancer Clinical TrialsClinicalTrials.gov
ClinicalTrials.gov provides information about publicly and privately supported clinical studies in the United States and around the world.
Search ClinicalTrials.govEmergingMed Clinical Trial Navigation Service
The EmergingMed Clinical Trial Navigation Service can help match people with cancer clinical trials based on information such as diagnosis, stage, and treatment history.
You can search online or request help from a Clinical Trial Navigator. Navigators can help identify possible trial matches, provide information about study sites, and help you understand next steps. The service is available at no cost to patients, caregivers, and physicians.
Explore EmergingMed Clinical Trial NavigationFORCE Research and Clinical Trials Search
For people with an inherited cancer risk or a family history that may suggest hereditary cancer, FORCE: Facing Our Risk of Cancer Empowered offers a research and clinical trials search tool.
The tool includes prevention, treatment, and quality-of-life studies for people with or at increased risk for hereditary cancers. It also provides information about finding studies, understanding eligibility, and enrolling in research.
Explore FORCE Research & Clinical Trials
Finding a possible trial does not mean you are automatically eligible. Your health care team and the trial staff will need to review the study requirements.
🎥 Watch: How clinical trials are expanding ovarian cancer treatment options
In this episode of Teal Talk, Dr. Michael Birrer discusses emerging ovarian cancer treatments, biomarker testing, personalized medicine, and why clinical trials are an important part of developing new treatment options.
Read the full article here.
What should I ask before joining a clinical trial?
Understanding the details of a study can help you decide whether participation is right for you.
Questions may include:
- Why is this trial being done?
- Why might this trial be appropriate for me?
- Am I eligible to participate?
- What type and phase of trial is this?
- What treatment will I receive?
- Is there a chance I will receive a different treatment because of randomization?
- What are the known and possible risks?
- What are the possible benefits?
- How often will I need appointments or testing?
- Can any visits be completed virtually or closer to home?
- How long might I participate?
- What costs will the study cover?
- Could I have travel or lodging expenses?
- Will my regular oncologist continue to be involved?
- What happens if I decide to leave the trial?
- What happens after my participation ends?
💡 Prepare for a conversation about clinical trials
Choosing whether to join a clinical trial can bring many questions.
NOCC’s Questions to Ask Your Doctor: Clinical Trials guide can help you discuss eligibility, benefits and risks, costs, travel, participant rights, and what to expect before and after a trial.
Download Questions to Ask Your Doctor: Clinical Trials
Understanding your clinical trial options
A clinical trial is one option to consider as part of your care. Deciding whether to participate is a personal decision.
Before joining a trial, make sure you understand:
- The purpose of the study
- Why you may be eligible
- The type and phase of the trial
- What treatment or intervention you may receive
- How treatment groups are assigned
- Required tests and appointments
- Possible risks and benefits
- Available standard treatment options
- Costs and insurance coverage
- Travel or time commitments
- Your rights as a participant
- What happens if you leave the study
- What happens after the trial ends
Talk with your health care team about how a clinical trial compares with your other options.
Frequently asked questions about clinical trials for ovarian cancer
No.
Clinical trials may be available at many points in care, including before treatment begins, during treatment, at recurrence, or during survivorship.
Some prevention and screening trials involve people who have never had ovarian cancer.
Not necessarily.
Some trials assign participants to different treatment groups through randomization. One group may receive the treatment being studied while another receives standard treatment or another comparison.
The informed consent process should explain how treatment assignment works before you enroll.
Learn more about how clinical trials are designed and how randomization works.
Often, yes, but the arrangement varies by study.
The clinical trial team may work with your regular oncologist and share information about your care. Ask who will manage different parts of your treatment before enrolling.
Yes.
Some ovarian cancer clinical trials are designed for cancers with specific genetic changes or tumor biomarkers.
Your pathology, genetic testing, and biomarker results may help your care team identify studies that could be relevant.
Learn more about genetic and biomarker tumor testing in ovarian cancer.
Not qualifying for one study does not mean there are no other options.
Different trials have different eligibility requirements. Ask your health care team whether another study or standard treatment may be appropriate.
More information about clinical trials