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Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas | Clinical Trials | Clareo Health

UNKNOWN

Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

NCT05127096•CellMax Life

View on ClinicalTrials.gov

Summary

The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•To enroll in Cohort A, a subject must:
•Be 45-80 years of age (inclusive) at the time of screening.
•Be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion.
•To enroll in Cohort B, a subject must:
•Be 45-80 years of age (inclusive) at the time of screening.
•Be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent.

Exclusion Criteria

•To enroll in Cohort A, a subject must NOT have:
•Inflammatory bowel disease (IBD)
•Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes
•To enroll in Cohort B, a subject must NOT have:
•Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
•Personal or family history of Familial adenomatous polyposis (FAP).
•Personal or family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome).
•Positive fecal occult blood testing (FOBT) within the previous 6 months.
•Positive fecal immunochemical testing (FIT) in the previous 6 months.
•Colorectal resection for any reason other than sigmoid diverticular disease.
+9 more criteria

Locations (15)

CellMax Site A

Huntsville, Alabama, United States

CellMax Site O

Chula Vista, California, United States

CellMax Site L

Lancaster, California, United States

CellMax Site J

Tustin, California, United States

CellMax Site P

Coral Gables, Florida, United States

CellMax Site D

Coral Springs, Florida, United States

CellMax Site G

Coral Springs, Florida, United States

CellMax Site C

Miami, Florida, United States

CellMax Site B

Metairie, Louisiana, United States

CellMax Site N

Mentor, Ohio, United States

Key Dates

Start Date

December 15, 2020

Primary Completion Date

September 30, 2022

Completion Date

December 30, 2022

Last Updated

November 19, 2021

Enrollment

1,000

ESTIMATED participants

Conditions

Colorectal Cancer Screening

Interventions

FirstSight blood test

DIAGNOSTIC_TEST

Contacts

Ben Hsieh, PhD

CONTACT

650-814-8088 ben@cellmaxlife.com

Stephen Su, PhD

CONTACT

408-887-7640 stephensu@cellmaxlife.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

Inclusion Criteria

Exclusion Criteria

Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection

Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.

Patient Navigation for Colorectal Cancer Screening

Pilot Testing of a Colorectal Cancer Education Program

Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.