Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2027-07-31

Brief Summary

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This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Detailed Description

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The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Conditions

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Colorectal Cancer

Keywords

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colorectal screening

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Arm A

Patients newly diagnosed with CRC who have not yet had treatment or surgery.

No interventions assigned to this group

Arm B

People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Arm A: Diagnosed with CRC
* Arm B: Undergoing screening with colonoscopy for CRC

Exclusion Criteria

* Arm A: Undergoing treatment for CRC,
* Arm B: Past history of CRC

Minimum Eligible Age

45 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Antonio Jesus Merino Calvo

Role: CONTACT

Phone: 674945571

Email: [email protected]

Facility Contacts

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Manish Bhuva, MD

Role: primary

Other Identifiers

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CRC-US-002

Identifier Type: -

Identifier Source: org_study_id