AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03688906 |
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Recruitment Status :
Completed
First Posted : September 28, 2018
Last Update Posted : March 2, 2022
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| Condition or disease |
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| Colo-rectal Cancer Cancer Colon Cancer, Rectum Neoplasms,Colorectal Polyps Polyp of Colon Adenoma Adenoma Colon |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 3275 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | Specimen Collection Study for Cancer |
| Actual Study Start Date : | January 12, 2018 |
| Actual Primary Completion Date : | November 25, 2019 |
| Actual Study Completion Date : | November 25, 2019 |
| Group/Cohort |
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Cohort A
Blood and stool specimen collection. Study samples must be collected prior to any treatment. |
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Cohort B
Blood and stool specimen collection. Samples must be collected prior to performing bowel preparation for the colonoscopy. |
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Cohort C
Blood and stool specimen collection. Study samples must be collected prior to any treatment. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
COHORT A
Inclusion Criteria:
- 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:
- 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.
COHORT B
Inclusion Criteria:
- 50-84 years of age (inclusive) at the time of screening
- 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
Key Exclusion Criteria:
- 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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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): NCT03688906
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| Principal Investigator: | Girish Putcha, M.D., Ph.D | Freenome Holdings Inc. |
Publications of Results:
| Responsible Party: | Freenome Holdings Inc. |
| ClinicalTrials.gov Identifier: | NCT03688906 |
| Other Study ID Numbers: |
AI-EMERGE/FRE-001 |
| First Posted: | September 28, 2018 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Liquid biopsy Blood test cancer Cancer diagnostic Genomics |
Genomic test AI genomics CRC Cancer screening |
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Rectal Neoplasms Adenoma Colorectal Neoplasms Polyps Colonic Polyps Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Intestinal Polyps Colonic Diseases |