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.

A doctor reviewing results on a clipboard with a patient.

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

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Colorectal cancer screening

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Liver cancer screening

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Multi-cancer screening

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Completed Studies

Detecting Cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) Study

Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention.
ALPHA-CORRECT
Alpha-CORRECT is a retrospective analysis of stage III colorectal cancer (CRC) participants in a prospective observational, multicenter study led by the University of Pittsburgh Medical Center (UPMC) to investigate the association of ctDNA with recurrence at pre-specified timepoints using the Oncodetect™ test.

BETA-CORRECT

Beta-CORRECT is a retrospective analysis of a cohort of stage II-IV CRC participants enrolled in a prospective observational, multicenter study led by the National Cancer Center of Japan to investigate the association of ctDNA with recurrence at pre-specified timepoints using the Oncodetect test.

Are you interested in participating in a clinical study?

Here’s what you can do and what you can expect:

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:

Review the study information and what to expect as a study participant.
Provide a form to be read and signed by the individual or their legal caregiver or guardian for permission to participate in the study.
Share written materials and verbal instructions, and answer questions about the study.

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:

Addressing barriers to equity in healthcare
Educating research providers and the community about the importance of diversity in clinical research
Including patient feedback into study design and planning.

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:

requiring participants to have a certain health conditions
age at the time of enrollment
whether a participant has previously been treated for the condition being studied.

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.

Where can I find additional information on clinical trials?

ClinicalTrials.gov: A database of publicly and privately funded clinical studies conducted around the world.

FDA: What Patients Need to Know about Clinical Trials