Colo-rectal CancerNCT03688906
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
An observational study of Colo-rectal Cancer and Cancer Colon, run by Freenome Holdings Inc. at 30 sites in 2 countries.
Trial summary
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum
- How many people
- 3,275 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 12 Jan 2018to 25 Nov 2019
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects for the study will be enrolled into three cohorts: * Cohort (A): People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated. * Cohort (B): People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy. * Cohort (C): People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Who may be able to join
- 50-84 years of age (inclusive) at the time of screening
- Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
- At least 7 days before but no more than 6 months after the most recent colonoscopy
- Able and willing to provide blood and stool (optional) samples per protocol
- Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
- 50-84 years of age (inclusive) at the time of screening
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- Planning to undergo a screening colonoscopy within 75 days after providing signed informed consent
- Able and willing to provide blood and stool (optional) samples per protocol
- Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
- At least 18 years of age (inclusive) at the time of screening
- Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
- At least 7 days before but no more than 6 months after the most recent colonoscopy
- Able and willing to provide blood and stool (optional) samples per protocol
- Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
Who cannot join
- Personal history of colorectal cancer, colorectal adenomas (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer (other than most recent diagnosis)
- Colonoscopy within the previous 9 years (other than most recent diagnosis)
- Overt rectal bleeding within the previous 30 days
- Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
- If female, known to be pregnant.
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- COHORT B
- Personal history of colorectal cancer, colorectal adenoma (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer
- Colonoscopy within the previous 9 years
- Overt rectal bleeding within the previous 30 days
- Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
- If female, known to be pregnant.
- COHORT C
- Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
- If female, be known to be pregnant.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Delta Research Partners
Bastrop, Louisiana, 71220
Washington Gastroenterology
Bellevue, Washington, 98004
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Del Sol Research Management
Chandler, Arizona, 85224
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Precision Research Institute
Chula Vista, California, 91910
Verity Research Inc
Fairfax, Virginia, 22031
Cumberland Research Associates
Fayetteville, North Carolina, 28304
Palmetto Research
Hialeah, Florida, 33016
Clinical Research of Homestead
Homestead, Florida, 33030
Clinical Research Associates
Huntsville, Alabama, 35801
The Jackson Clinic
Jackson, Tennessee, 38305
Preferred Research Partners
Little Rock, Arkansas, 72211
New Orleans Research Institute
Metairie, Louisiana, 70006
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Advanced Research Institute
Ogden, Utah, 84405
Quality Clinical Research
Omaha, Nebraska, 68114
Diverse Research Solutions
Oxnard, California, 93030
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684
Wake Research Associates
Raleigh, North Carolina, 27612
Rockford Gastroenterology
Rockford, Illinois, 61107
Precision Research Institute
San Diego, California, 92114
Louisiana Research Center
Shreveport, Louisiana, 71105
Del Sol Research Management,
Tucson, Arizona, 85710
Del Sol Research Management
Tucson, Arizona, 85745
Trial Management Associates
Wilmington, North Carolina, 28403
Canada1 site
Forzani and MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6
About this study
Official title: Specimen Collection Study for Cancer
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.
Read the detailed description
Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.
Freenome is looking for three types of patients in this study:
Cohort A:
People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Cohort B:
People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.
Cohort C:
People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
- Conditions
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal, Polyps, Polyp of Colon
- Keywords
- Liquid biopsy, Blood test cancer, Cancer diagnostic, Genomics, Genomic test, AI genomics, CRC, Cancer screening
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Polyps, Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Blood and stool specimen collection. Study samples must be collected prior to any treatment. | |
| Cohort B | Blood and stool specimen collection. Samples must be collected prior to performing bowel preparation for the colonoscopy. | |
| Cohort C | Blood and stool specimen collection. Study samples must be collected prior to any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy
Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start12 Jan 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,275 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Freenome Holdings Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Putcha, M.D., Ph.D, Principal investigator, Freenome Holdings Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688906
- Sponsor's protocol ID
- AI-EMERGE/FRE-001
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Putcha G, Liu T-Y, Ariazi E, Bertin M, Drake A, Dzamba M, Hogan G, Kothen-Hill S, Liao J, Li K, Mahajan S, Palaniappan K, Sansanwal P, St John J, Ulz P, Wan N, Warsinske H, Weinberg D, Yang R, Lin J. Blood-based detection of early-stage colorectal cancer using multiomics and machine learning. [Abstract] J Clin Oncol 38 (Suppl 4): A-66, 2020.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Collection Study for Cancer
- ClinicalTrials.gov ID
- NCT03688906
- Acronym / sponsor ID
- AI-EMERGE/FRE-001
- Conditions
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal, Polyps, Polyp of Colon
- Keywords
- Liquid biopsy, Blood test cancer, Cancer diagnostic, Genomics, Genomic test, AI genomics, CRC, Cancer screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,275 participants (actual)
- Lead sponsor
- Freenome Holdings Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 28 Sep 2018 (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.
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.
Detailed description
Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.
Freenome is looking for three types of patients in this study:
Cohort A:
People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Cohort B:
People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.
Cohort C:
People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Blood and stool specimen collection. Study samples must be collected prior to any treatment. |
| Cohort B | – | –Blood and stool specimen collection. Samples must be collected prior to performing bowel preparation for the colonoscopy. |
| Cohort C | – | –Blood and stool specimen collection. Study samples must be collected prior to any treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects for the study will be enrolled into three cohorts: * Cohort (A): People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated. * Cohort (B): People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy. * Cohort (C): People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Key inclusion criteria (14 listed)
- 50-84 years of age (inclusive) at the time of screening
- Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
- At least 7 days before but no more than 6 months after the most recent colonoscopy
- Able and willing to provide blood and stool (optional) samples per protocol
- Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
Key exclusion criteria (17 listed)
- Personal history of colorectal cancer, colorectal adenomas (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer (other than most recent diagnosis)
- Colonoscopy within the previous 9 years (other than most recent diagnosis)
- Overt rectal bleeding within the previous 30 days
- Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy
Time frame: 6 months
Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Results publicationPutcha G, Liu T-Y, Ariazi E, Bertin M, Drake A, Dzamba M, Hogan G, Kothen-Hill S, Liao J, Li K, Mahajan S, Palaniappan K, Sansanwal P, St John J, Ulz P, Wan N, Warsinske H, Weinberg D, Yang R, Lin J. Blood-based detection of early-stage colorectal cancer using multiomics and machine learning. [Abstract] J Clin Oncol 38 (Suppl 4): A-66, 2020.
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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.
Girish Putcha, M.D., Ph.D principal investigator
Freenome Holdings Inc.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Cancer Colon, run by Freenome Holdings Inc. at 30 sites in 2 countries.
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 14 inclusion and 17 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688906, which also lists 1 linked publication.
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 2 Mar 2022.