免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Plasma-based Colorectal Cancer Screening Research & Development
Plasma-based Colorectal Cancer Screening Research & Development
Study Description
Brief 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 preparation.
| Condition or disease | Intervention/treatment |
|---|---|
| Colo-rectal Cancer | Diagnostic Test: Epi proColon |
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
| Study Type : | Observational |
| Actual Enrollment : | 354 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development |
| Actual Study Start Date : | May 3, 2019 |
| Actual Primary Completion Date : | March 31, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Diagnostic Test: Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
|
|
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
|
Diagnostic Test: Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
|
Outcome Measures
Primary Outcome Measures :
- 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
Biospecimen Retention: Samples With DNA
EDTA plasma samples
Eligibility Criteria
| Ages Eligible for Study: | 45 Years to 84 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1).
Criteria
Inclusion Criteria: Group 1
- 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.
Inclusion Criteria: Group 2
- Willing and able to sign an Informed Consent and adhere to study requirements.
- 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.
Exclusion Criteria: Group 1
- 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.
Exclusion Criteria: Group 2
- 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).
- 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.
Contacts and Locations
Locations
| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Springfield Clinic | |
| Springfield, Illinois, United States, 62702 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70170 | |
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Pennsylvania | |
| University of Pennsylvania Perelman Center for Advanced Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Epigenomics, Inc
Investigators
| Study Director: | Theo deVos, PhD | Epigenomics, Inc |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 6, 2019 | ||||||
| First Posted Date | July 22, 2019 | ||||||
| Last Update Posted Date | February 2, 2021 | ||||||
| Actual Study Start Date | May 3, 2019 | ||||||
| Actual Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Plasma-based Colorectal Cancer Screening Research & Development | ||||||
| Official Title | Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development | ||||||
| Brief 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 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 Type | Observational | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples With DNA Description:
EDTA plasma samples
|
||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1). | ||||||
| Condition | Colo-rectal Cancer | ||||||
| Intervention | Diagnostic Test: Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
|
||||||
| Study Groups/Cohorts |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
354 | ||||||
| Original Estimated Enrollment |
400 | ||||||
| Actual Study Completion Date | March 31, 2020 | ||||||
| Actual Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria: Group 1
Inclusion Criteria: Group 2
Exclusion Criteria: Group 1
Exclusion Criteria: Group 2
|
||||||
| Sex/Gender |
|
||||||
| Ages | 45 Years to 84 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04027790 | ||||||
| Other Study ID Numbers | ECS0001 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Epigenomics, Inc | ||||||
| Study Sponsor | Epigenomics, Inc | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
||||||
| PRS Account | Epigenomics, Inc | ||||||
| Verification Date | February 2021 | ||||||
