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Colorectal Cancer ScreeningNCT02419716

A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

An observational study of Colorectal Cancer Screening and Colorectal Cancer, run by Exact Sciences Corporation at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
What is being tested?
Cologuard
Type of treatment
Medical device
How many people
2,404 participants
Where
40 sitesUnited States
Study dates
Apr 2015to 16 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study will enroll approximately 2,400 men and women aged 50 years and older at a minimum of 20 sites to achieve a minimum of 1,119 subjects at the Year 3 visit. To increase the point prevalence of CRC in the study population, subject enrollment will be age-weighted toward a slightly older population. Enrollment of at least 65% of subjects age 65 years or older will be targeted

Who may be able to join

  • Subject has been prescribed Cologuard for colorectal cancer screening
  • Subject is at average risk for development of colorectal cancer
  • Subject is 50 years or older
  • Subject willing and able to sign informed consent.

Who cannot join

  • Subject had a colonoscopy in the previous 9 years
  • Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
  • Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  • Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
  • Subject has a history of colorectal cancer or advanced adenoma.
  • Subject has a history of aerodigestive tract cancer
Show all 16Show fewer
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
  • Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
  • Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
  • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
  • 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
  • One first-degree relative with CRC diagnosed before the age of 60.
  • Subject has a family history of:
  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
  • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • The Kaufmann Clinic, Inc.

    Atlanta, Georgia, 30308

  • Austin Regional Clinic

    Austin, Texas, 78759

  • United Medical Associates

    Binghamton, New York, 13901

  • Cassidy Medical Group/Radiant Research, Inc.

    Carlsbad, California, 92008

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Sentral Clinical Research

    Cincinnati, Ohio, 45236

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Centennial Medical Associates

    Elkridge, Maryland, 21075

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Pharmakon Inc

    Evergreen Park, Illinois, 60805

  • Paragon Rx Clinical

    Garden Grove, California, 92840

  • Thomas C Lenzmeier, M.D., P.C

    Glendale, Arizona, 85308

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Nevada Family Care

    Henderson, Nevada, 89074

  • Homestead Medical Research

    Homestead, Florida, 33030

  • Indiana University, Eskanazi Hospital, Regenstrief Health Center

    Indianapolis, Indiana, 46202

  • Health Awareness, Inc

    Jupiter, Florida, 33458

  • Precision Clinical Research

    Lauderdale Lakes, Florida, 33319

  • UCLA, Division of Digestive Diseases

    Los Angeles, California, 90095

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • MedPharmics, LLC

    Metairie, Louisiana, 70006

  • Advanced Bioresearch

    Miami, Florida, 33134

  • Next Phase Research Alliance

    Miami, Florida, 33144

  • FACEY Medical Foundation

    Mission Hills, California, 91345

  • PCP for Life (DM Research)

    Montgomery, Texas, 77356

  • John D. Homan, MD

    Newport Beach, California, 92663

  • Diverse Research Solutions

    Oxnard, California, 93030

  • Ventura County Gastroenterology

    Oxnard, California, 93030

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Health Awareness, Inc-Port St. Lucie

    Port Saint Lucie, Florida, 34984

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905

  • Advanced Pain Diagnostics & Solutions

    Sacramento, California, 95825

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Fiel Family and Sports Medicine

    Tempe, Arizona, 85283

  • Comprehensive Internal Medicine, Inc.

    Wooster, Ohio, 44691

  • Family Practice Center of Wooster, Inc./Clinical Trial Developers

    Wooster, Ohio, 45150

Other trials in United States

About this study

Official title: A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.

Read the detailed description

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.

Being tested
Cologuard
Keywords
colorectal cancer, Colorectal cancer screening
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CologuardDevice

    Prescription of Cologuard for at-home stool collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive and Negative Predictive Value

    The difference between the positive predictive value (PPV) at year 3 (PPV3) and 1 minus the negative predictive value (NPV) at year 3 (NPV3).

    Measured: Three years

Secondary outcomes (1)

  1. Colorectal Cancer Incidence

    Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02419716
Sponsor's protocol ID
Exact Sciences 2014-01
Status last verified
Apr 2020
First submitted
9 Apr 2015
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer Screening and Colorectal Cancer, run by Exact Sciences Corporation at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Predictive Value (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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