Status:
COMPLETED
Plasma-based Colorectal Cancer Screening Research & Development
Lead Sponsor:
Epigenomics, Inc
Conditions:
Colo-rectal Cancer
Eligibility:
All Genders
45-84 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
May 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT04027790
Start Date
May 3 2019
End Date
March 31 2020
Last Update
February 2 2021
Active Locations (5)
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1
University of South Florida
Tampa, Florida, United States, 33606
2
Springfield Clinic
Springfield, Illinois, United States, 62702
3
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70170
4
Washington University
St Louis, Missouri, United States, 63110