PRECISION MEDICINE AND MOLECULAR TESTING

Personalized medicine and Precision Medicine are interchangeable terms. They are the practice of using cutting-edge science to tailor treatments to your unique personal biology.

At Cure Forward, we prefer precision medicine because it is a more accurate description for treatments based on genomics and genetics.

Genomics examines large segments of DNA, or your entire set of DNA as a whole, while genetics looks at the working of individual genes inside your DNA.

At Cure Forward we refer to this as molecular testing or having a molecular profile. This is the first step in accessing precision medicine.

Precision medicine starts with a test that examines many of your genes at once, finding the ones that are changed or behaving abnormally.

For patients, precision medicine could mean less frequent, extra targeted therapies and potential better outcomes. As a patient, it is a treatment approach to discuss with your physician.

Molecular testing, sometimes called tumor sequencing or tumor profiling, is a method of testing that examines a patient’s particular cancer and studies its genetic characteristics as well as any other biomarkers that may have significance. This information is used to identify therapies that are more likely to work for that specific tumor profile.

Not all cancer is created equal. Cancer is a disease caused by changes called “mutations” inside your cells. When DNA, RNA, and proteins develop hundreds, or even thousands, of changes – cancer can result. Molecular testing examines and catalogs these changes. Read more on the benefits of testing here.

Mutations are changes in your DNA.

They may be germline mutations that are inherited by parents and raises an individual’s risk for cancer. While a particular mutation may be common within a family, inherited cancer mutations are rare in the general population.

They may also be acquired mutations, sometimes called somatic mutations, which are found in every cancer case. These are ‘errors’ in the DNA that arise during the normal cell replication process. Environmental exposure such as sunlight, chemical fumes and smoking can increase the chance of error and cause mutation. A mutation affecting a gene that is involved in cell life cycle regulation can result in cancer, where cells divide out of control.

We are still in the early days of molecular testing. Researchers and physicians understand that cancer with certain genetic alterations respond well to certain treatments. But science has not yet unlocked all the secrets of the cancer genome.

The goals for molecular testing development are:

  • To expose the weaknesses of every form of cancer and tailor therapies to individual patients
  • To develop treatments that can distinguish between healthy and cancerous tissue, therefore causing fewer side effects.

Molecular testing identifies biomarkers – mutated genes, proteins, or other molecules – known to influence how patients respond to specific treatments. These tests can help doctors craft a treatment plan that responds to your unique form of cancer at a particular moment in time. They can also help researchers learn to fight the cancer of future patients more effectively.

Joining Cure Forward will give you access to information about cancer and cancer research and allow you to search our Clinical Trial Exchange. You can join Cure Forward without having a molecular profile but having this information helps us offer you more targeted information and will help you explore your options with greater clarity.

CLINICAL TRIALS

Clinical trials are where transformational therapies are proven. Patients who participate in clinical trials have the opportunity to access and potentially benefit from these therapies early, and to help prove or disprove their use for future generations of patients. It’s important to note there is no guarantee that a new, potential treatment will work and unknown or negative effects are possible.

Clinical trials have both potential risks and benefits. They test pre-FDA approved therapies for treatment of disease in humans. The choice of whether to participate in a clinical trial should be carefully weighed.

However, any potential new treatment must undergo vigorous review by the FDA before it can be given to patients. Before clinical trials are approved, an Investigational Review Board (IRB), and ethicists – that typically include both scientists and laypeople – examine the plan for testing the new treatment. This is to ensure the study meets ethical guidelines and does not pose an undue risk to patients.

Any approved trial must obtain “informed consent” from each patient who participates in a clinical trial. This means that the sponsor of the trial must explain the purpose of the study, the potential risks of participating in the trial – such as the potential risks of a new treatment being investigated – all in language and a format that is understandable.

At minimum, all patients in a cancer treatment clinical trial receive the best standard treatment, called the “standard-of-care,” in addition to any new treatments being tested. Four boards of experts, including the researchers, monitor the safety of the trial as it progresses and may stop the trial early if there are concerns about safety or if enough data is collected early.

Clinical trials benefit people with many different types of cancer and at all stages of the disease.  Clinical trials may offer the best treatment available for certain individuals.

Research and discovery move so fast for some cancers that the treatment under clinical trials may be better than the current standard treatment. People who participate in clinical trials can be the first to benefit from new treatments. That’s why it’s so important to consider all of your options, including clinical trials.

Read more about the possible risks and benefits of clinical trials here 

Insurance and research sponsors often cover the cost of clinical trials. According to federal law, health insurers must cover approved clinical trials that you enroll in if you’re eligible for the study. Please note that insurance doesn’t always cover everything – if the trial uses out-of-network hospitals, insurance only has to pick up those costs if you have out-of-network coverage. Trial sponsors will typically pick up research costs, like extra blood tests, since insurance doesn’t have to pay for those.

You can learn more about the costs of care in clinical trials here.

New treatments move through different phases. Treatments go through three or more phases of clinical testing and must be reviewed and approved by the FDA before they are released to the general patient population. Phase 1 clinical trials look at whether a treatment is safe. Then the treatment passes into Phase 2 and 3 clinical trials, which generally seek to evaluate the drug’s effectiveness and identify the appropriate dose and best method of administering it. Read more about patient safety in clinical trials from the National Cancer Institute.

Learn more about the different phases of clinical trials.

CLINICAL TRIALS EXCHANGE

It is our goal to help patients know and evaluate all of the potential treatment options, including clinical trials.  Clinical Trials may be part of your treatment journey but are often hard to find. The CTX connects patients and trial recruiters based on information provided by patients and the search criteria of the trials. It allows patients to be seen by trial recruiters across the US.

If considered a potential match for a trial, trial recruiters can then send invitations directly to patients on Cure Forward. Patients review invitations and discuss the risks and benefits with their physician.    

When you choose to post to the CTX, you instantly make your molecular and clinical criteria, plus your location preferences, available to all recruiting trials on Cure Forward. Trial recruiters receive notifications when patients that may fit their trials post to the CTX. Trial recruiters then send invitations to those that meet the needs of their trial.

Clinical trial recruiters will never be able to see any information that could reveal your identity. As a patient, you only hear from trials that are actively recruiting and actively interested in you.

If you decide to accept an invitation, we will introduce you to the designated contact for that clinical trial site through email and phone. This contact will be responsible for answering your questions and walking you through the trial application process.

The clinical trial site is responsible for processing your application. Through the application process, the clinical trial site will determine if you’re a good candidate for the trial or if the trial isn’t right for you.

All of your invitations will stay active for 30 days from the end of your posting period. You may decide at any time not to pursue a trial. You may also learn through the designated contact that you’re not a good candidate.  To not proceed with a trial or review your other invitations, you will need to close out the first acceptance and choose another one.

The CTX saves your previous posts, making it easy post again with the click of a button. New trials are always being added to the CTX, so come back and post again to see if you are a candidate for any new trials. If you’ve received additional treatments or test results since your last post, you may also want to add that information to your patient profile to ensure the most appropriate matches.

New trials become available on a rolling basis and you can refresh your post often. The post is stored on the system so it may be re-posted with a single click. You can also review and update your posting and profile anytime.

In the meantime, you may want to visit our community and connect with others who may share similar experiences and insights.

It is important to note that not every patient will use Cure Forward and not every clinical trial will be listed, especially as we build the CTX over the coming months.

At Cure Forward, it is our goal to provide access to the most suitable trials.

During the CTX intake questionnaire, we will ask you where you live and how far you are willing to travel (or any other cities that you may have access to) to participate in a clinical trial. This allows us to find trials outside your immediate area that you may want to consider.

You can specify if you don’t want to travel.  We will then only show you choices accessible to your hometown.

Yes.  Understanding the information behind your disease and all the treatment options available will help you be a better partner to your doctor. There are considerable risks to clinical trials that need to be talked through and considered carefully.

Talking to your doctor about all of the options will help ensure you are working together for the best treatment plan.

Only trials currently searching for patients will extend invitations to you.  You will only see invitations for trials that are actively recruiting.

CURE FORWARD

Today, Cure Forward is helping cancer patient’s access precision medicine. As new research brings the genetics of other health conditions into focus, we hope to continue to expand.

There are many companies that take a sample of your DNA and analyze it to show your ancestral makeup and other features.  This is different than molecular profiling specifically for disease treatment.

We have partnered with diagnostic test providers that offer molecular tests specially designed for cancer patients trying to get more precise diagnoses and treatment options to allow you to more easily obtain your data. Learn more about our diagnostic test providers here.

Cure Forward does not offer analysis, testing, or interpretation of the data.  The information that we provide, such as our Gene Stories and CTX, are designed to help patients expand their knowledge and put you closer to practical options that you can discuss with your physician.

No, there are no charges for patients to access Cure Forward.

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