Colorectal CancerPERTNCT03218423
Longitudinal Performance of Epi proColon
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Epigenomics, Inc at 6 sites in United States.
Trial summary
This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Epi proColon
- Type of treatment
- Medical device
- How many people
- 4,500 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Aug 2017to Jan 2024
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be the population defined in the intended use statement, i.e. adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines will be offered and declined prior to offering the Epi proColon test. Eligible subjects will be recruited at a regular visit at their primary health care provider, or through typical preventive care outreach by health care providers. Consented subjects who agree to participate in the study and agree to be tested with Epi proColon will be enrolled.
Who may be able to join
- Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
- Subjects who have a history of non-compliance for CRC screening.
- After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
- Subjects who are 50 years of age or greater, but less than 75 years old.
- Subjects who are able to understand and sign written informed consent (IC).
Who cannot join
- Subjects defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
- Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
- Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), 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, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
- Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
- Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
- Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnant women.
Trial locations and contacts
6 sites in 1 country.
Neil Mucci contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Geisinger Health System
Danville, Pennsylvania, 17822
Kay Reiner, MPH, BSN, RN, 570-214-5421, kmreiner1@geisinger.edu
Amy Howell-Harte, MD
- Recruiting
Duke University
Durham, North Carolina, 27704
Kim Leathers, 919-668-5589, kimberly.leathers@duke.edu
Kathy Chmielewski, 919-668-7863, kathy.chmielewski@duke.edu
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
Elyse Krupp, 304-581-1913, jennifer.krupp@hsc.wvu.edu
Dorian Williams, MD
- Recruiting
Rutgers University Hospital
New Brunswick, New Jersey, 08901
Marie Macor, 732-235-8143, macorma@rwjms.rutgers.edu
Greg Riedlinger, MD, PhD
- Recruiting
Beaumont Health System
Royal Oak, Michigan, 48073
Karen Barger-Smith, 248-551-1556, karen.barger-smith@beaumont.org
Maureen Cooney, 248-551-0099, maureen.cooney@beaumont.org
- Recruiting
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161
Debora Goodman, 858-552-8585 ext. 6797, Debora.Goodman@va.gov
Samir Gupta, MD
About this study
Official title: Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.
Read the detailed description
Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.
The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Epi proColon
- Keywords
- screening, plasma, DNA methylation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi proColonDevice
Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in test specificity between initial testing and repeat testing 1 year
- Subjects will be tested with blood-based Epi proColon assay at initial enrollment, and tested again 1 year later (positive or negative test results)
- Subjects with positive test results with Epi proColon assay are referred to colonoscopy. Colonoscopy outcomes will be recorded (no evidence of disease or CRC)
- The difference in test specificity between initial and follow-up visits will be recorded.
Measured: Through study completion, expected at 60 months
Detection of colorectal cancer
Findings of colorectal cancer in subjects with a colonoscopy following a positive Epi proColon test will be recorded.
Measured: Through study completion, expected at 60 months
Secondary outcomes (4)
Adherence to testing
The adherence to repeated Epi proColon testing by patients who had a negative initial Epi proColon result will be recorded.
Measured: Through study completion, expected at 60 months
Adherence to colonoscopy
The rate of adherence to colonoscopy for patients with a positive Epi proColon result will be recorded
Measured: Through study completion, expected at 60 months
Diagnostic Yield
All procedure results will be recorded for patients who complete a colonoscopy evaluation following a positive Epi proColon test
Measured: Through study completion, expected at 60 months
Assay Failure Rate
The Epi proColon assay failure rate will be recorded during the duration of the study
Measured: Through study completion, expected at 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start18 Aug 2017
- Primary completionAug 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theo deVos, PhD, Study director, Epigenomics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218423
- Sponsor's protocol ID
- SPR 0028
- Acronym
- PERT
- Status last verified
- Oct 2021
- First submitted
- 14 Jun 2017
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Potter NT, Hurban P, White MN, Whitlock KD, Lofton-Day CE, Tetzner R, Koenig T, Quigley NB, Weiss G. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clin Chem. 2014 Sep;60(9):1183-91. doi: 10.1373/clinchem.2013.221044. Epub 2014 Jun 17.
PubMed 24938752Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
PubMed 24901436
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
- ClinicalTrials.gov ID
- NCT03218423
- Acronym / sponsor ID
- PERT / SPR 0028
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- screening, plasma, DNA methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Jul 2017 (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.
This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.
Detailed description
Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.
The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be the population defined in the intended use statement, i.e. adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines will be offered and declined prior to offering the Epi proColon test. Eligible subjects will be recruited at a regular visit at their primary health care provider, or through typical preventive care outreach by health care providers. Consented subjects who agree to participate in the study and agree to be tested with Epi proColon will be enrolled.
Key inclusion criteria (5 listed)
- Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
- Subjects who have a history of non-compliance for CRC screening.
- After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
- Subjects who are 50 years of age or greater, but less than 75 years old.
- Subjects who are able to understand and sign written informed consent (IC).
Key exclusion criteria (6 listed)
- Subjects defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
- Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
- Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), 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, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
- Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
- Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
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 |
|---|---|---|
| Epi proColonPlasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening. | Device | – |
Primary outcome
The difference in test specificity between initial testing and repeat testing 1 year
Time frame: Through study completion, expected at 60 months
* Subjects will be tested with blood-based Epi proColon assay at initial enrollment, and tested again 1 year later (positive or negative test results) * Subjects with positive test results with Epi proColon assay are referred to colonoscopy. Colonoscopy outcomes will be recorded (no evidence of disease or CRC) * The difference in test specificity between initial and follow-up visits will be recorded.
Detection of colorectal cancer
Time frame: Through study completion, expected at 60 months
Findings of colorectal cancer in subjects with a colonoscopy following a positive Epi proColon test will be recorded.
4 secondary outcomes
Adherence to testing
Time frame: Through study completion, expected at 60 months
Adherence to colonoscopy
Time frame: Through study completion, expected at 60 months
Diagnostic Yield
Time frame: Through study completion, expected at 60 months
Assay Failure Rate
Time frame: Through study completion, expected at 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 24938752Potter NT, Hurban P, White MN, Whitlock KD, Lofton-Day CE, Tetzner R, Koenig T, Quigley NB, Weiss G. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clin Chem. 2014 Sep;60(9):1183-91. doi: 10.1373/clinchem.2013.221044. Epub 2014 Jun 17.
- Background: PubMed 24901436Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
- FDA Epi proColon product pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
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.
Neil Mucci contact
Theo deVos, PhD study director
Epigenomics, Inc
6 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 and Colorectal Neoplasms, run by Epigenomics, Inc at 6 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theo deVos, PhD (2068832916, theo.devos@epigenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in test specificity between initial testing and repeat testing 1 year (time frame: Through study completion, expected at 60 months). The study lists 2 primary outcomes in all. 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 NCT03218423, which also lists 2 linked publications.
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 1 Nov 2021.