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

Last updated: November 9, 2021
Sponsor: CellMax Life
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT05127096
PRO00100
  • Ages 45-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 tosurgically 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 signedinformed consent.

Exclusion

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 cancersyndromes To enroll in Cohort B, a subject must NOT have:
  • Personal history of colorectal cancer, colorectal adenoma or aerodigestive tractcancer.
  • 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) andCrohn'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: Firstdegree 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 whichan experimental medication has been administered during the 30 days up to andincluding the date of providing informed consent or may be administered through thetime of the colonoscopy.
  • Have a medical condition which, in the opinion of the investigator, should precludeenrollment into the study.

Study Design

Total Participants: 1000
Study Start date:
December 15, 2020
Estimated Completion Date:
December 30, 2022

Connect with a study center

  • CellMax Site A

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • CellMax Site O

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • CellMax Site L

    Lancaster, California 93534
    United States

    Active - Recruiting

  • CellMax Site J

    Tustin, California 92780
    United States

    Active - Recruiting

  • CellMax Site P

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • CellMax Site D

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • CellMax Site G

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • CellMax Site C

    Miami, Florida 33125
    United States

    Active - Recruiting

  • CellMax Site B

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • CellMax Site N

    Mentor, Ohio 44060
    United States

    Active - Recruiting

  • CellMax Site M

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • CellMax Site K

    Houston, Texas 77084
    United States

    Active - Recruiting

  • CellMax Site E

    McAllen, Texas 78539
    United States

    Active - Recruiting

  • CellMax Site F

    Pasadena, Texas 77504
    United States

    Active - Recruiting

  • CellMax Site H

    San Antonio, Texas 78212
    United States

    Active - Recruiting

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