Clinical studies
Learning you may have or be at risk for cancer is hard. But getting ahead of it is becoming easier. Exact Sciences has a vision to help you discover and eradicate cancer early through one-of-a-kind tests that screen for cancer or help identify targeted treatments for your specific cancer.
Exact Sciences has developed a range of tests that can catch cancer before you know it or give you important information about the genes responsible for your diagnosed cancer. With this information in hand, you and your doctor can confidently choose a treatment path that may be most effective and personalized for you.
Right now, these tests focus on colorectal and breast cancers. But our scientific teams are also busy researching more cancers and developing multi-cancer testing to help many more people in the future. We're pleased to share some of our current clinical studies that will allow us to bring great new tests to patients.
At Exact Sciences, we conduct a range of clinical studies to rigorously assess the safety and performance of our tests in order to detect cancer earlier and guide optimal treatment.
We're pleased to highlight below some of our current clinical study efforts.
Active studies
Molecular residual disease
CORRECT-I
CORRECT-II
For more information, refer to the clinicaltrials.gov link below. To find a participating site near you, please contact the NSABP Department of Site and Study Management at 1-800-270-3165 or by e-mail at
EXActDNA-003/NSABP B-64
Exact Sciences and NSABP Foundation are working together on an observational study called EXActDNA-003/NSABP B-64. This study is for adults with high-risk, early-stage breast cancer, who will be receiving chemotherapy before surgical treatment. The aim of this study is to collect multiple blood samples over 5.5 years to evaluate if an investigational blood test is able to predict breast cancer recurrence.
For more information, or to find a participating site near you, refer to the clinicaltrials.gov link below.
EXActDNA-004/FH-PrwS-07-002
Exact Sciences and Flatiron Health are working together on an observational study for adults diagnosed with an early stage (I, II or III) solid tumor cancer that is eligible for surgical removal or has recently been surgically removed. The aim of this study is to collect tumor tissue and multiple blood samples over 5.5 years to determine if Exact’s MRD test is able to predict cancer recurrence and to support the development of other tests to improve cancer detection.
For more information, or to find a participating site near you, refer to the clinicaltrials.gov link below.
Colorectal cancer screening
VOYAGE
Exact Sciences and Mayo Clinic are working together on a clinical survey study to gather long-term health information from people who have been prescribed the Cologuard® test. Participants who receive a Cologuard test may be invited to participate by mail. Participants will be asked to complete a baseline health questionnaire survey (T0), a 1-year follow-up questionnaire survey (T1), allow future contact for additional surveys, and may allow access to medical records as available.
For more information, refer to the link below.
Liver cancer screening
ALTUS
Exact Sciences is currently conducting a clinical study called ALTUS, which is enrolling patients who are at increased risk for a type of liver cancer called hepatocellular carcinoma (HCC). In the study, participants will have radiology exams to check if HCC is developing and also provide blood samples for the Oncoguard® Liver blood test. The goal of the ALTUS study is to determine how well the Oncoguard Liver blood test can detect HCC in this patient population.
For more information, refer to the link below.
Multi-cancer screening
Falcon Registry
Exact Sciences is conducting the Falcon Registry study, a multi-site study to collect real-world evidence from up to 25,000 patients being tested with the Exact Sciences MCED test—a multi-cancer early detection (MCED) test. The Falcon Registry study aims to collect data about the course of care and outcomes for patients who are tested with the Exact Sciences MCED test under development, as well as any impact the testing may have on patient anxiety. The study will also gather data from a set of up to 50,000 patients who have received only single-cancer standard-of-care screening and will compare these data to those who were tested with the Exact Sciences MCED test. Those who enroll in the study will be offered the Exact Sciences MCED test once a year for up to three years and data will be collected for up to 5 years.
For more information, refer to the link below.
Completed Studies
Detecting Cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) Study
BETA-CORRECT
Are you interested in participating in a clinical study?
Reach out to your doctor to ask about a clinical study that seems related to your condition. Alternatively, your provider may suggest you participate in a specific clinical study that could help treat your condition.
Study staff will ask you a few questions to see if you meet the requirements to join the study.
If you meet the eligibility requirements, a team of medical professionals will thoroughly discuss the study with you, give you time to ask questions, and review the informed consent form. Once you feel comfortable and have all your questions answered, you’ll provide written permission to start your participation in the study.
Arrive at the clinic for your first visit! After that, you will continue to come in for visits according to the clinical study schedule.
Frequently asked questions
What types of clinical studies does Exact Sciences conduct?
The two main types that Exact Sciences conducts are interventional studies and observational studies.
Interventional Clinical Studies
In an interventional clinical study, participants receive a specific intervention, which could be:
- a unique medication,
- a new treatment schedule,
- a test, or
- a medical procedure.
The intervention is then compared to the current standard of care for that condition.
This type of clinical study is often designed to determine whether the new intervention is more effective or no different than the standard of care.
Observational Studies
In observational studies, clinical researchers observe and collect information about the participants to measure health outcomes.
Participants are not assigned to a specific intervention or compared to a different group of patients. Instead, researchers identify and enroll people who have already received a treatment or test in the past for a specific condition and analyze those results.
During the study, participants may be asked to answer questions, and report side effects or other challenges. They may also be asked to contribute biological samples, such as blood, saliva, or tissue that the researcher can test and use for their observations.
How can clinical study participants learn more about the study?
Before participating in a clinical study, the potential benefits, risks and alternatives to the study are shared with interested individuals. This is called informed consent.
During the informed consent process, a study staff member will:
The goal of this process is to make sure that every study participant understands the commitment they are making.
What is meant by diversity in clinical studies?
Diversity is important to a study because biological, social, and economic factors can affect how people respond to a drug, test, or other intervention. To make sure that a scientific finding applies to everyone, studies should represent the broad community. This includes a wide range of ages, genders, races, ethnicities, insurance statuses, and other considerations.
At Exact Sciences, we are dedicated to increasing diversity in our clinical studies by:
Who approves and monitors clinical studies?
An Institutional Review Board (IRB) is a group of clinicians, scientists, patient advocates, and community members. They are tasked with reviewing and approving clinical study protocols (plans), informed consent (written permissions to participate in a study) requirements and other study related materials. Studies involving human participants must be reviewed by an IRB before they can begin and are monitored throughout the study period. The IRB process safeguards the rights and welfare of clinical study participants. The IRB ensures that studies are well designed, ethical, legal and safe.
Who can participate in clinical studies?
Anyone can participate in a clinical study if they meet the qualifications for that study. Some common factors that may be considered for study enrollment include:
If you are interested in participating in a clinical study, your doctor or study staff at the research site can help you determine if you meet participation qualifications.
Can I withdraw from a clinical study after starting?
Yes. Participating in a clinical study is voluntary and you can end your participation at any time and for any reason.