Every research study enrolling patients should provide an outline of who may participate in the study. This is known as eligibility. Eligibility is further categorized by a set of requirements known as inclusion criteria and exclusion criteria. All studies in our Research Study Search Tool list basic eligibility. Listed below are some of the most common factors that may affect your eligibility to participate in research. If you are unsure about your eligibility for a study, don’t be shy about reaching out to the study contact. An important part of their role in the study is to help people learn if they are eligible.
Factors that affect eligibility
The following factors may affect your eligibility for a particular study. Often this information about your cancer risk or diagnosis is located in your medical records. This is why it is helpful to have your medical records on hand before you look for a research study.
Cancer diagnosis
Treatment studies are sometimes open only to people with a particular type or subtype of cancer. The information about your tumor type and subtype is available in your medical records in a section known as the pathology report. Some studies require tissue samples for participation. You may need to order your tissue samples from the hospital that performed your surgery. Some studies require you to have an additional biopsy. Check the study listing or call the contact person to learn about the tissue sample requirements for the study.
- Type of cancer
- Some treatment studies are open only to people with a particular type of cancer, while others may be open to people with one of several types of cancer. Studies may be open to anyone with a solid tumor. Breast, ovarian, pancreatic, prostate and melanoma, and other cancers are considered solid tumors.
- Cancer subtype
- Cancers may be defined by certain features within the cancer cells, including tumor markers or how the cancer cells appear under a microscope.
- Cancer stage
- Clinical trials are not only for people who have run out of treatment options. They are available for every stage of cancer and even precancerous conditions. Some treatment studies are open only to people with early stage cancers while some may be open only to people with advanced or metastatic cancers.
- Site of cancer spread
- Clinical trial eligibility may be based on where the cancer has spread, e.g., some studies may exclude patients whose cancer has spread to the brain. If you have metastatic (advanced) cancer, it may be helpful to know where your tumor has spread before searching clinical trials.
Current or prior treatment
Treatment studies sometimes exclude patients who have already had a certain number of treatments, or a certain type of treatment. If you have been newly diagnosed with cancer, or have recently experienced a recurrence, it may be helpful to search clinical trials before starting treatment if possible. If you are unsure or cannot remember which treatments you have received, this information is usually located within your medical records.
- Surgery and neo-adjuvant studies
- Some clinical trials, especially breast cancer neo-adjuvant studies may be open only to people who have not yet had surgery to remove their cancer.
- Medical therapy
- Some studies enroll only patients who have received a certain treatment, while other studies may exclude people who have received certain treatments. Some studies are only open to patients with cancer that has progressed after a certain number of treatments.
- Treatment studies for advanced or recurrent cancer commonly require patients to be off of any other treatment for a specified period of time before enrolling in the clinical trial.
Genetic test results
Our Research Study Search Tool includes studies for people who have had genetic testing, and people who have not. If you have had genetic testing, it will be helpful to have a copy of your results when you search for clinical trials.
- Many of the studies in our database are open to people with an inherited mutation in a gene associated with increased cancer risk, such as BRCA1BRCA1, MLH1BRCA2, PALB2PALB2 CHE ATM and others. To find studies specifically for people with your mutation, enter the name of the gene, e.g., BRCA1 in the keyword search field.
- If you have not had genetic testing, some studies will include the testing as part of screening to participate.
Other medical conditions or procedures
Diabetes, liver, kidney disease and other medical decisions besides cancer may affect your eligibility to enroll in a research study. Procedures, such as risk-reducing salpingo-oophorectomy may make you eligible or ineligible for certain clinical trials.
Access to experimental treatments
If you have exhausted all treatment options for advanced cancer, you may want to participate in research to gain access to a new or experimental treatment but find that you are ineligible for a clinical trial. Some pharmaceutical companies may allow expanded access to a new drug that is not yet approved by the FDA. To apply for expanded access to an agent, you should contact the company that makes the agent. You will need your oncologist to fill out paperwork and the approval process may take several weeks.