Thyroid Cancer Clinical Trials Update Show 001

Every Monday 10:30 AM Eastern Standard Time The Thyroid Cancer Coffee Break will share information on clinical trials and research studies in the fight to prevent, cure and treat thyroid cancer currently accepting participants nationwide. 

Have a pencil and paper handy to write down the contact information for programs.  Please email questions before the show to info@sjccfthynet.org  subject line: Clinical Trials

Listen to internet radio with Calamity Sunshine on Blog Talk Radio

Hereditary Cancer Risk Assessment Basics

The goal of most hereditary cancer programs is to provide individual risk assessment that can be incorporated into the patient’s ongoing medical care. The programs usually evaluates families with multiple members with cancer (of the same or different type) for the purpose of assessing the likelihood of a hereditary cancer syndrome. Patients are usually referred by their physician based upon their personal medical and/or family histories.

Often several sessions are required. The initial session includes a review of the patient’s medical history as well as three generational family history. The counselor will review this information within the context of risk for a hereditary cancer syndrome. The benefits, risks and limitations of testing will be described in detail. Often testing options can be offered at an initial visit. However, sometimes it is necessary to collect medical records on affected family members in order to understand the risk that exists for the patient and family. 

Genetic testing will then be offered if appropriate. If the patient decides to proceed with testing a final appointment is scheduled to review the results in person. This visit includes interpretation of the results a discussion of how this information affects medical management and the impact on the extended family. 

Some important factors that would indicate this type of evaluation include:

• Cancer that developed at an early age, usually less than 50.
• Individuals with rare cancer i.e. male breast cancer.
• More than one primary cancer in an affected individual.
• Other physical signs such as colon polyps, moles, desmoids tumors, thyroid nodules, and fatty tumors.
• Different cancers in a family that are known to be genetically related such as breast and ovarian cancers.
• Several generations in the family affected by cancer.
• Clustering of cancers that are known to be genetically related (such as breast and ovarian, colon and uterine and breast and thyroid).
• Breast or ovarian cancer and Ashkenazi (eastern European) Jewish ancestry.
• An identified genetic mutation in the family.
• Known cancer syndrome in the family (for example Lynch syndrome, Cowden syndrome, MEN and others).

FOR MORE INFORMATION PLEASE TALK TO YOUR DOCTOR OR CLICK HERE 

Clinical Trial Basics

• Clinical trials are research studies that involve people. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

• In cancer research a clinical trial is designed to show how a particular anticancer strategy—for instance, a promising drug, a gene therapy treatment, a new diagnostic test, or a possible way to prevent cancer—affects the people who receive it.

• A clinical trial is one of the stages of a long and careful cancer research process. Getting promising results from testing a new drug on mice, for example, is a preliminary step to human research studies. Treatments that work well in mice do not always work well in people.

• People can benefit from clinical trials. In treatment trials, for example, participants receive high-quality cancer care—and will be among the first to benefit if a new approach is proven to work.

• Only eligible people can participate in a clinical trial. Each study has its own guidelines for who can participate. Generally, participants are alike in key ways—such as the type and stage of cancer, age, gender, and other factors.

• There may be drawbacks. New treatments under study are not always better than, or even as good as, standard care. And they may have unexpected side effects. Through a process called “informed consent” you will learn about a study’s treatments and tests, and their possible benefits and risks, before deciding whether or not to participate.

• In treatment trials involving people who have cancer, placebos are very rarely used.

• Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known for a cancer, based on results of past research. In these studies patients are randomly assigned to one group or another.

• Clinical trials take place all over the country—in cancer centers, other major medical centers, community hospitals and clinics, physicians’ offices and veterans’ and military hospitals.

• Health plans and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. Ask a doctor, nurse, or social worker form the study to help you determine in advance what costs are covered. The research costs, such as data management, are covered by the study sponsor.

How To Learn More About Clinical Trials:  

1. Call the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) and ask for a customized search of the PDQ database, which provides information on current studies.
2. National Institutes of Health Web Sites with Lists of Clinical Trials, plus further general information about clinical trials:

• http://www.clinicaltrials.gov

• http://www.cancer.gov/search/clinical_trials

SOURCE: Ten Things to Know About Treatment Clinical Trials From the National Cancer Institute, National Institutes of Health Bethesda, Maryland NIH Publication No. 00-4830

Is a Clinical Trial for You?

Cancer is and has been one of the most active areas in medical research worldwide for decades. At any time, hundreds of clinical trials are under way on new cancer drugs, treatments or combinations of exisiting treatments.  Many trials may be withing your geographic area. That means you may have access to the very latests treatment for your type and stage of cancer -- even if that drug or treatment option is not on the market yet.

Clinical trials (also called clinical research studies) evaluate new drugs the U.S. Food and Drug Administration (FDA) hasn't yet approved or test new uses for already approved drugs. They also evaluate new combinations of existing drugs and treatments, different dosages of approved drugs, or find the best time to begin using a particular drug or treatment.

How Do Clinical Trials Start?

Every new medication begins in the laboratory. Pharmaceutical company researchers test hundreds of thousands of compounds every year, searching for the few that may prove beneficial. From the time they identify such a compound until it reaches the market (if it does) it could take 10 years or more and cost hundreds of millions of dollars.

Once compounds show promise in laboratory and animal studies, companies apply to the FDA for permission to conduct human clinical trials. These trials occur in four phases designed to determine specific information, such as risks, safety, and effectiveness compared with a standard drug or therapy.

Each phase is strictly regulated and evaluated, and the safety of the participating is always the top priority. If there are any safety concerns, officials will halt the trial. Only after a cancer drug has been shown to be safe and effective -- or more effective, or otherwise better than existing ones -- does the FDA approve it for sale in the United States of America.

Why Participate in Clinical Trials?

When you volunteer for a cancer clinical trial, you are guaranteed to receive either the treatment under investigation or the best available standard of care treatment. Unlike clinical studies in other therapeutic areas, patients in cancer clinical trials receive a "sugar pill" placebo ONLY if no standard treatment exists, therefore make sure you know if this is the case before signing up for a cancer clinical trial.

Patients in cancer clinical trials also receive increased monitoring and attention from nurses and  doctors due to being in the trial. Other benefits in a cancer clinical trial include:

• You may receive access to innovative new treatments that aren't available anywhere else.
• It offers another option if your cancer has become resistant to treatment or has re-ocurred.
• You can help further medical research not only for yourself but for other cancer patients as well.

Are Clinical Trials Safe?

All cancer or medical treatments carry risks, even those that have been used by thousands of patients. Not all treatments prove to be better that the standard of care and may produce additional side effects. Yet all clinical trials must meet rigourous guidelines designed to protect you. You will be monitored very closely during the trial  for any potential side effects or problems. Also, healthcare professionals involved in the study will explain any known or anticipated risks to you before you commit to the trial. This is part of the informed consent process.

What is Informed Consent?

Informed consent is your right as a clinical trial participant. A document will outline the purpose of the study (clinical trial), the exact treatments you will receive, all possible side effects (known or anticipated) and your right to withdraw at any point. Signing the informed consent form acknowledges that the trial was explained to you and you understand it. However, you can withdraw from a clinical trial at any time , even after signing the form.

Phases of a Clinical Trial:

A clinical trial typically includes four phases of testing and information collection as follows:

Phase 1  This stage tests the safety of a potential new drug or therapy on a small number of humans to find the best dosage and potential side effects.

Phase 2   Using the dose and schedules determined in Phase 1, this stage discovers more about how effective the treatment is for patients.

Phase 3   This stage compares the new drug or therapy with a standard therapy in a randomised study involving hundreds of participants.

Phase 4   After the drug is approved for marketing this stage lets pharmaceutical companies gather more information as the drug is used in thousands of patients and conduct additional trials investigating other uses for it.  

How Do I Participate in a Clinical Trial?

If you are interested in participating in a clinical trial, talk to your doctor. Cancer doctors are usually aware of ongoing studies. Very often, they are helping to conduct a trial by having some of their patients participate. Clinical trials are conducted in hospitals, universities, cancer centers, clinics, and even doctor's offices.

Get Help With Decision Making:

Ask questions before signing up for a clinical trial.   Choosing to be in a clinical trial is an important personal decision. Discuss the following questions with your healthcare team to make an informed choice and decision about which clinical trial you participate in.

• What is the purpose of this trial?
• How ill I benefit?
• What are the potential risks?
• What will be required of me and my family?
• What kinds of test and procedures are involved?
• Do I have to change doctors to be in the trial, or can I stay with my own doctor?
• How will I learn the final result of the study?
• Will I be paid or do I have to pay to participate in the study?
• What follow-up is involved once my treatment in the trial ends?
• What treatment will I receive if I do not participate in this clinical trial?

Please remember your healthcare team and family doctor are the best sources of information for your individual care. If you have any questions about this article or you are interested in clinical trials talk to your doctor.

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Stevie JoEllie's Cancer Care Fund is working to develop and launch an access to care grant program for thyroid cancer patients and survivors nationwide. Please consider supporting our unique initiative that includes a set aside fund for healthcare access to assist thyroid cancer survivors with medical costs associated with follow up treatment, annual exams,  diagnostics and medications. 

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