CRC Screening
Conditions
Brief summary
The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. The main questions it aims to answer are: * Does Gixam give the same result when the test is repeated on the same day, with the same device and the same staff member (repeatability)? * Does Gixam give the same result when the test is done on different days, with different devices and different staff members (reproducibility)? Participants will: * Answer questions about their health, medicines, diet, alcohol and tobacco use, and oral care habits * Have the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 * On Days 7 and 14, report when they last ate, drank or smoked, and whether they brushed, scraped their tongue or used mouthwash * Then join the main Gixam study (CL-1009) for a FIT stool test and their planned colonoscopy
Interventions
DEVICEGixam System
Repeated Gixam tests, 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14
Sponsors
Jubaan Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Participants aged ≥45 - ≤84 years. 2. Able to provide a signed informed consent. 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC. 4. Scheduled for a screening colonoscopy at investigation site.
Exclusion criteria
1. Undergoing colonoscopy for investigation of symptoms. 2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention. 3. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months. 4. Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years. 5. History of colorectal cancer. 6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age. 7. Participant has a diagnosis or medical / family history of any of the following conditions, including: * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome) * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome") * Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis. 8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease. 9. Participants with a disability to extend their tongue. 10. Participants with tongue tremor. 11. Participants with tongue piercing. 12. Participants that had a dental visit in the 7 days prior to the Gixam test. 13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test. 14. Participants that have taken probiotics in the 14 days prior to the Gixam test. 15. Participant is pregnant. 16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | From enrollment to the end of the study at 14 days after | Number of device-related adverse events and serious adverse events. |
| Gixam repeatability - precision within-system-within-operator of all Runs | Through study completion, an average of 14 days | Success criteria 1. NPA lower limit of the two-sided 95% confidence interval \> 85% 2. PPA lower limit of the two-sided 95% confidence interval \> 80% |
| Gixam reproducibility - precision between-system-between-operator of all Systems/Operators | Through study completion, an average of 14 days | Success criteria 1. NPA lower limit of the two-sided 95% confidence interval \> 80% 2. PPA lower limit of the two-sided 95% confidence interval \> 75% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gixam reported continuous probability score | Through study completion, an average of 14 days | This endpoint will be used to calculate variability across the repeated assessments (standard deviations and coefficients of variation). |
Countries
United States
Outcome results
None listed