Clinical trial NCT05127096: Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Screening
Lead sponsor: CellMax Life
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Sensitivity for CRC of the FirstSight test
timeFrame: 30 days
measure: Specificity of the FirstSight test
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: CellMax Site A
state: Alabama
city: Chula Vista
country: United States
facility: CellMax Site O
state: California
city: Lancaster
country: United States
facility: CellMax Site L
state: California
city: Tustin
country: United States
facility: CellMax Site J
state: California
city: Coral Gables
country: United States
facility: CellMax Site P
state: Florida
city: Coral Springs
country: United States
facility: CellMax Site D
state: Florida
city: Coral Springs
country: United States
facility: CellMax Site G
state: Florida
city: Miami
country: United States
facility: CellMax Site C
state: Florida
city: Metairie
country: United States
facility: CellMax Site B
state: Louisiana
city: Mentor
country: United States
facility: CellMax Site N
state: Ohio
city: Camp Hill
country: United States
facility: CellMax Site M
state: Pennsylvania
city: Houston
country: United States
facility: CellMax Site K
state: Texas
city: McAllen
country: United States
facility: CellMax Site E
state: Texas
city: Pasadena
country: United States
facility: CellMax Site F
state: Texas
city: San Antonio
country: United States
facility: CellMax Site H
state: Texas
Study officials:
affiliation: CellMax Life
name: Rui Mei, PhD
role: STUDY_DIRECTOR
References: