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

Colorectal Cancer Screening Clinical Trial

Official title:

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 Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127096
• Other study ID #: PRO00100
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: CellMax Life
• Contact: Ben Hsieh, PhD
• Phone: 650-814-8088
• Email: ben[@]cellmaxlife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.
• Overt rectal bleeding within the previous 30 days.
• Personal history of any cancer diagnosed <5 years prior.
• Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease.
• Colonoscopy within the previous 9 years.
• Barium enema, computed tomographic colonography, or sigmoidoscopy within the previous 5 years.
• = 2 first-degree relatives who have been diagnosed with colorectal cancer (Note: First degree relatives include parents, siblings and offspring).
• 1 first-degree relative with CRC diagnosed before the age of 60.
• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 30 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer Screening
• Colorectal Neoplasms
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• FirstSight blood test
FirstSight blood test for colorectal cancer screening

Locations

Country	Name	City	State
United States	CellMax Site M	Camp Hill	Pennsylvania
United States	CellMax Site O	Chula Vista	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 K	Houston	Texas
United States	CellMax Site A	Huntsville	Alabama
United States	CellMax Site L	Lancaster	California
United States	CellMax Site E	McAllen	Texas
United States	CellMax Site N	Mentor	Ohio
United States	CellMax Site B	Metairie	Louisiana
United States	CellMax Site C	Miami	Florida
United States	CellMax Site F	Pasadena	Texas
United States	CellMax Site H	San Antonio	Texas
United States	CellMax Site J	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
CellMax Life

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for CRC of the FirstSight test		30 days
Primary	Specificity of the FirstSight test		30 days