Recruiting

Early Detection

Sponsor:

CellMax Life

Code:

NCT05127096

Conditions

Colorectal Cancer Screening

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

FirstSight blood test

Study Details

Brief 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.

Conditions

Colorectal Cancer Screening

Study ID

NCT05127096

Start date

Dec 15, 2020

Status verified date

Nov, 2021

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A

Cohort A will include subjects with a recent diagnosis of colorectal cancer and/or advanced adenoma requiring additional endoscopic or surgical resection (surgery).

Cohort B

Cohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort.

Interventions

FirstSight blood test

FirstSight blood test for colorectal cancer screening

Primary outcome measure

  • Sensitivity for CRC of the FirstSight test [ Time Frame: 30 days ]
  • Specificity of the FirstSight test [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Ben Hsieh, PhD

650-814-8088ben@cellmaxlife.com

Stephen Su, PhD

408-887-7640stephensu@cellmaxlife.com

Locations

CellMax Site O

Recruiting

Chula Vista, California, United States, 91910

CellMax Site L

Recruiting

Lancaster, California, United States, 93534

CellMax Site J

Recruiting

Tustin, California, United States, 92780

CellMax Site P

Recruiting

Coral Gables, Florida, United States, 33134

CellMax Site D

Recruiting

Coral Springs, Florida, United States, 33067

CellMax Site G

Recruiting

Coral Springs, Florida, United States, 33067

CellMax Site C

Recruiting

Miami, Florida, United States, 33125

CellMax Site B

Recruiting

Metairie, Louisiana, United States, 70006

CellMax Site N

Recruiting

Mentor, Ohio, United States, 44060

CellMax Site M

Recruiting

Camp Hill, Pennsylvania, United States, 17011

CellMax Site K

Recruiting

Houston, Texas, United States, 77084

CellMax Site E

Recruiting

McAllen, Texas, United States, 78539

CellMax Site F

Recruiting

Pasadena, Texas, United States, 77504

CellMax Site H

Recruiting

San Antonio, Texas, United States, 78212

More Information

Sponsor

CellMax Life

Last update posted

Nov 19, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CellMax Life on 2021-11-19.