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

November 9, 2021 updated by: CellMax Life
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Active, not recruiting
        • CellMax Site A
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • CellMax Site O
      • Lancaster, California, United States, 93534
        • Recruiting
        • CellMax Site L
      • Tustin, California, United States, 92780
        • Recruiting
        • CellMax Site J
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • CellMax Site P
      • Coral Springs, Florida, United States, 33067
        • Recruiting
        • CellMax Site D
      • Coral Springs, Florida, United States, 33067
        • Recruiting
        • CellMax Site G
      • Miami, Florida, United States, 33125
        • Recruiting
        • CellMax Site C
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • CellMax Site B
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • CellMax Site N
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • CellMax Site M
    • Texas
      • Houston, Texas, United States, 77084
        • Recruiting
        • CellMax Site K
      • McAllen, Texas, United States, 78539
        • Recruiting
        • CellMax Site E
      • Pasadena, Texas, United States, 77504
        • Recruiting
        • CellMax Site F
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • CellMax Site H

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort A: This cohort will include subjects with a recent diagnosis of colorectal cancer or advanced adenoma requiring surgical resection.

Cohort B: This cohort will include subjects undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical assessment regimen.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Diagnostic test: FirstSight blood test
FirstSight blood test for colorectal cancer screening
Cohort B
Cohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort.
Diagnostic test: FirstSight blood test
FirstSight blood test for colorectal cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity for CRC of the FirstSight test
Time Frame: 30 days
30 days
Specificity of the FirstSight test
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellMax Life

Investigators

  • Study Director: Rui Mei, PhD, CellMax Life

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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