Colorectal CancerNCT03705013
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 20 sites in United States.
Trial summary
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cologuard
- How many people
- 51 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Oct 2018to 16 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: There are four sub-populations of the Cologuard Post-Approval Study (2014-01) under observation: positive first Cologuard test and negative colonoscopy or no colonoscopy and positive 3-year follow-up Cologuard test and negative colonoscopy or no colonoscopy.
Who may be able to join
- Subject falls into one of the 4 sub-populations
- Willing to provide informed consent
Who cannot join
- Death
- Investigator/sponsor decision
- Subject withdrew consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
The Kaufmann Clinic
Atlanta, Georgia, 30308
Austin Regional Clinic
Austin, Texas, 78759
Cassidy Medical Group
Carlsbad, California, 92008
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Innovative Research of West Florida
Clearwater, Florida, 33756
Centennial Medical Group
Elkridge, Maryland, 21075
Thomas C Lenzmeier, M.D., P.C.
Glendale, Arizona, 85308
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
Jupiter, Florida, 33458
Family Practice Center of Wooster
Massillon, Ohio, 44647
Central Arizona Medical Associates, PC
Mesa, Arizona, 85206
PCP for Life
Montgomery, Texas, 77356
John D. Homan, MD
Newport Beach, California, 92663
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
Health Awareness Inc., Port St. Lucie
Port Saint Lucie, Florida, 34984
Mayo Clinic
Rochester, Minnesota, 55905
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Fiel Family and Sports Medicine, PC
Tempe, Arizona, 85206
About this study
Official title: Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
Read the detailed description
Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.
- Conditions
- Colorectal Cancer
- Being tested
- Cologuard
- Keywords
- Cologuard
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CologuardOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Baseline Cologuard positive and negative colonoscopy | Those whose Cologuard T0 result was positive and colonoscopy result was negative. Receives: Other: Cologuard | |
| Baseline Cologuard positive and no colonoscopy | Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Receives: Other: Cologuard | |
| 3-year follow-up Cologuard positive and negative colonoscopy | Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Receives: Other: Cologuard | |
| 3-year follow-up Cologuard positive and no colonoscopy | Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Receives: Other: Cologuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with discordant results that can be attributed to intercurrent disease
A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.
Measured: 3 years after positive Cologuard result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start30 Oct 2018
- Primary completion16 Nov 2019
- Study completion16 Nov 2019
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705013
- Sponsor's protocol ID
- 2018-09
- Status last verified
- Apr 2020
- First submitted
- 24 Sep 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study
- ClinicalTrials.gov ID
- NCT03705013
- Acronym / sponsor ID
- 2018-09
- Conditions
- Colorectal Cancer
- Keywords
- Cologuard
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 16 Nov 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
Detailed description
Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline Cologuard positive and negative colonoscopy | – | Other: CologuardThose whose Cologuard T0 result was positive and colonoscopy result was negative. |
| Baseline Cologuard positive and no colonoscopy | – | Other: CologuardThose whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. |
| 3-year follow-up Cologuard positive and negative colonoscopy | – | Other: CologuardThose whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. |
| 3-year follow-up Cologuard positive and no colonoscopy | – | Other: CologuardThose whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are four sub-populations of the Cologuard Post-Approval Study (2014-01) under observation: positive first Cologuard test and negative colonoscopy or no colonoscopy and positive 3-year follow-up Cologuard test and negative colonoscopy or no colonoscopy.
Key inclusion criteria (2 listed)
- Subject falls into one of the 4 sub-populations
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- Death
- Investigator/sponsor decision
- Subject withdrew consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CologuardObservational | Other | 3-year follow-up Cologuard positive and negative colonoscopy, 3-year follow-up Cologuard positive and no colonoscopy, Baseline Cologuard positive and negative colonoscopy, Baseline Cologuard positive and no colonoscopy |
Primary outcome
The number of subjects with discordant results that can be attributed to intercurrent disease
Time frame: 3 years after positive Cologuard result
A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 20 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 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 20 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
The number of subjects with discordant results that can be attributed to intercurrent disease (time frame: 3 years after positive Cologuard result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020; AzTrials last refreshed its copy on 4 Nov 2026.