Colo-rectal CancerNCT04027790
Plasma-based Colorectal Cancer Screening Research & Development
An observational study of Colo-rectal Cancer, run by Epigenomics, Inc at 5 sites in United States.
Trial summary
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel… Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Epi proColon
- How many people
- 354 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 May 2019to 31 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 45 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1).
Who may be able to join
- Willing and able to sign an Informed Consent and adhere to study requirements.
- Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality).
- Colonoscopy diagnosis of colorectal cancer (CRC).*
- Blood sampling a minimum of 7 days after colonoscopy and before resection surgery.
- = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report.
- Willing and able to sign an Informed Consent and adhere to study requirements.
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- Eligible for colorectal cancer screening colonoscopy.
- 45 - 84 years of age at blood sampling.
- Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy.
Who cannot join
- Subject with curative biopsy during colonoscopy.
- Current neoadjuvant treatment.
- Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
- Known infection with HIV, HBV or HCV.
- Previous personal history of CRC, adenomatous polyps >10mm or sessile serrated adenomas (polyps).
- Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP).
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- History of inflammatory bowel disease.
- Current neoadjuvant treatment.
- Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
- infection with HIV, HBV or HCV.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ochsner Clinic Foundation
New Orleans, Louisiana, 70170
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Springfield Clinic
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.
Read the detailed description
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.
- Conditions
- Colo-rectal Cancer
- Being tested
- Epi proColon
- Keywords
- plasma, cell-free DNA, DNA Methylation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi proColonDiagnostic test
Analysis of DNA methylation status for Septin9 and additional biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Cancer Patients | Subjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment Receives: Diagnostic Test: Epi proColon | |
| Group 2 - Screening Subjects | Prospectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test Receives: Diagnostic Test: Epi proColon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Positivity
DNA methylation status of Epi proColon and biomarker panel
Measured: Anticipated time frame for testing blood sample is within 12 months of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start3 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
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
- NCT04027790
- Sponsor's protocol ID
- ECS0001
- Status last verified
- Feb 2021
- First submitted
- 6 Jun 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
- ClinicalTrials.gov ID
- NCT04027790
- Acronym / sponsor ID
- ECS0001
- Conditions
- Colo-rectal Cancer
- Keywords
- plasma, cell-free DNA, DNA Methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Jul 2019 (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 objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.
Detailed description
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Cancer Patients | – | Diagnostic Test: Epi proColonSubjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment |
| Group 2 - Screening Subjects | – | Diagnostic Test: Epi proColonProspectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1).
Key inclusion criteria (9 listed)
- Willing and able to sign an Informed Consent and adhere to study requirements.
- Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality).
- Colonoscopy diagnosis of colorectal cancer (CRC).*
- Blood sampling a minimum of 7 days after colonoscopy and before resection surgery.
- Willing and able to sign an Informed Consent and adhere to study requirements.
Key exclusion criteria (10 listed)
- Subject with curative biopsy during colonoscopy.
- Current neoadjuvant treatment.
- Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
- Known infection with HIV, HBV or HCV.
- Previous personal history of CRC, adenomatous polyps >10mm or sessile serrated adenomas (polyps).
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 proColonAnalysis of DNA methylation status for Septin9 and additional biomarkers | Diagnostic test | Group 1 - Cancer Patients, Group 2 - Screening Subjects |
Primary outcome
Test Positivity
Time frame: Anticipated time frame for testing blood sample is within 12 months of collection
DNA methylation status of Epi proColon and biomarker panel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
Theo deVos, PhD study director
Epigenomics, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Epigenomics, Inc at 5 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 9 inclusion and 10 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Test Positivity (time frame: Anticipated time frame for testing blood sample is within 12 months of collection). 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 2 Feb 2021.