Advanced Adenocarcinoma, Colorectal Cancer, Serrated Polyp
Conditions
Brief summary
This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.
Detailed description
This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. Subjects were recruited onto the clinical trial if they were average-risk subjects, or had a self-reported family history of CRC, aged 45 and older. All participants completed the ColoSense test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The ColoSense test result (positive or negative) was compared with index lesions observed on colonoscopy. The primary outcomes included ColoSense sensitivity for detecting colorectal cancer, advanced adenomas, or serrated precancerous lesions, and ColoSense specificity for all other findings.
Interventions
DIAGNOSTIC_TESTColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Sponsors
Geneoscopy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. Subjects were recruited onto the clinical trial if they were average-risk subjects, or had a self-reported family history of CRC, aged 45 and older. All participants completed the ColoSense test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The ColoSense test result (positive or negative) was compared with index lesions observed on colonoscopy. The primary outcomes included ColoSense sensitivity for detecting colorectal cancer, advanced adenomas, or serrated precancerous lesions, and ColoSense specificity for all other findings.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is male or female, ≥45 years of age * Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form * Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure * Subject is able and willing to undergo a colonoscopy after providing a stool sample
Exclusion criteria
* Subject had any precancerous finding on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable) * Subject has a history or diagnosis of colorectal cancer * Subject has a history of aerodigestive tract cancer * Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals: * Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months * FIT-DNA test within the previous 36 months * Subject has had a colonoscopy in the previous nine (9) years * Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease * Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding) * Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer: * Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease * Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP) * Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCC of Lynch Syndrome) * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ColoSense Sensitivity for Advanced Adenoma (AA) | 120 days from stool sample collection |
| ColoSense Sensitivity for Serrated Precancerous Lesions (SPL) | 120 days from stool sample collection |
| ColoSense Specificity for Negative Findings | 120 days from stool sample collection |
| ColoSense Sensitivity for Colorectal Cancer (CRC) | 120 days from stool sample collection |
Countries
United States
Participant flow
Recruitment details
Participants were engaged using an online social media platform through a decentralized recruitment effort. Interested participants completed a self-reported online survey to screen for the intended use population and to obtain socioeconomic and demographic information. Enrolled participants provided both written and oral informed consent to complete study requirements and provide medical records.
Pre-assignment details
Of the 14,263 subjects enrolled in the CRC-PREVENT study, 8,920 completed all study requirements and 7,763 subjects were considered average-risk.
Participants by arm
| Arm | Count |
|---|---|
| Average Risk Subjects Average risk subjects were required to submit a ColoSense test prior to completing a colonoscopy. Subjects were considered eligible for the primary analysis if they were 45 years or older, male or female, met eligibility criteria, and did not report a first degree relative with colorectal cancer. | 7,763 |
| Total | 7,763 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5,301 |
| Overall Study | Non Average-risk | 1,157 |
| Overall Study | Withdrawal by Subject | 42 |
Baseline characteristics
| Characteristic | Average Risk Subjects |
|---|---|
| Age, Continuous | 55.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 500 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 142 Participants |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 64 Participants |
| Race/Ethnicity, Customized Asian | 307 Participants |
| Race/Ethnicity, Customized Black / African American | 821 Participants |
| Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander | 17 Participants |
| Race/Ethnicity, Customized Other | 286 Participants |
| Race/Ethnicity, Customized White | 6268 Participants |
| Region of Enrollment United States | 7763 participants |
| Sex/Gender, Customized Female | 4643 Participants |
| Sex/Gender, Customized Male | 3111 Participants |
| Sex/Gender, Customized Other | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14,263 |
| other Total, other adverse events | 1 / 14,263 |
| serious Total, serious adverse events | 0 / 14,263 |
Outcome results
Primary
ColoSense Sensitivity for Advanced Adenoma (AA)
Time frame: 120 days from stool sample collection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Advanced Adenoma (AA) | Positive | 231 Participants |
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Advanced Adenoma (AA) | Negative | 283 Participants |
Primary
ColoSense Sensitivity for Colorectal Cancer (CRC)
Time frame: 120 days from stool sample collection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Colorectal Cancer (CRC) | Positive | 25 Participants |
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Colorectal Cancer (CRC) | Negative | 2 Participants |
Primary
ColoSense Sensitivity for Serrated Precancerous Lesions (SPL)
Time frame: 120 days from stool sample collection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Serrated Precancerous Lesions (SPL) | Positive | 22 Participants |
| Colorectal Cancer Subjects (Average Risk) | ColoSense Sensitivity for Serrated Precancerous Lesions (SPL) | Negative | 76 Participants |
Primary
ColoSense Specificity for Negative Findings
Time frame: 120 days from stool sample collection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Colorectal Cancer Subjects (Average Risk) | ColoSense Specificity for Negative Findings | Positive | 1027 Participants |
| Colorectal Cancer Subjects (Average Risk) | ColoSense Specificity for Negative Findings | Negative | 6097 Participants |