Colorectal Cancer ScreeningNCT05127096
Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas
An observational study of Colorectal Cancer Screening, run by CellMax Life at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- FirstSight blood test
- How many people
- 1,000 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 Dec 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites, 14 recruiting
- Recruiting
CellMax Site M
Camp Hill, Pennsylvania, 17011
- Recruiting
CellMax Site O
Chula Vista, California, 91910
- Recruiting
CellMax Site P
Coral Gables, Florida, 33134
- Recruiting
CellMax Site D
Coral Springs, Florida, 33067
- Recruiting
CellMax Site G
Coral Springs, Florida, 33067
- Recruiting
CellMax Site K
Houston, Texas, 77084
- Active, not recruiting
CellMax Site A
Huntsville, Alabama, 35801
- Recruiting
CellMax Site L
Lancaster, California, 93534
- Recruiting
CellMax Site E
McAllen, Texas, 78539
- Recruiting
CellMax Site N
Mentor, Ohio, 44060
- Recruiting
CellMax Site B
Metairie, Louisiana, 70006
- Recruiting
CellMax Site C
Miami, Florida, 33125
- Recruiting
CellMax Site F
Pasadena, Texas, 77504
- Recruiting
CellMax Site H
San Antonio, Texas, 78212
- Recruiting
CellMax Site J
Tustin, California, 92780
About this study
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
- Being tested
- FirstSight blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirstSight blood testDiagnostic test
FirstSight blood test for colorectal cancer screening
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: FirstSight blood test | |
| Cohort B | Cohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort. Receives: Diagnostic Test: FirstSight blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for CRC of the FirstSight test
Measured: 30 days
Specificity of the FirstSight test
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start15 Dec 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellMax Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Mei, PhD, Study director, CellMax Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127096
- Sponsor's protocol ID
- PRO00100
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05127096
- Acronym / sponsor ID
- PRO00100
- Conditions
- Colorectal Cancer Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- CellMax LifeIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: FirstSight blood testCohort A will include subjects with a recent diagnosis of colorectal cancer and/or advanced adenoma requiring additional endoscopic or surgical resection (surgery). |
| Cohort B | – | Diagnostic Test: FirstSight blood testCohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- Inflammatory bowel disease (IBD)
- Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FirstSight blood testFirstSight blood test for colorectal cancer screening | Diagnostic test | Cohort A, Cohort B |
Primary outcome
Sensitivity for CRC of the FirstSight test
Time frame: 30 days
Specificity of the FirstSight test
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Mei, PhD study director
CellMax Life
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Screening, run by CellMax Life at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Hsieh, PhD (650-814-8088, ben@cellmaxlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for CRC of the FirstSight test (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.