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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05127096
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
CellMax Life

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Screening Diagnostic Test: FirstSight blood test

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity for CRC of the FirstSight test [ Time Frame: 30 days ]
  2. Specificity of the FirstSight test [ Time Frame: 30 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127096


Contacts
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Contact: Ben Hsieh, PhD 650-814-8088 ben@cellmaxlife.com
Contact: Stephen Su, PhD 408-887-7640 stephensu@cellmaxlife.com

Locations
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United States, Alabama
CellMax Site A Active, not recruiting
Huntsville, Alabama, United States, 35801
United States, California
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
United States, Florida
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
United States, Louisiana
CellMax Site B Recruiting
Metairie, Louisiana, United States, 70006
United States, Ohio
CellMax Site N Recruiting
Mentor, Ohio, United States, 44060
United States, Pennsylvania
CellMax Site M Recruiting
Camp Hill, Pennsylvania, United States, 17011
United States, Texas
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
Sponsors and Collaborators
CellMax Life
Investigators
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Study Director: Rui Mei, PhD CellMax Life
More Information
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Responsible Party: CellMax Life
ClinicalTrials.gov Identifier: NCT05127096    
Other Study ID Numbers: PRO00100
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes