CRC Screening, Microbiome
Conditions
Brief summary
The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are: 1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result? 2. Is the use of the Gixam device safe? Gixam test result will be compared to the findings of a standard of care screening colonoscopy. Study participants will: 1. Undergo the Gixam test 2. Take a FIT at home and ship to a laboratory. 3. Undergo a standard of care screening colonoscopy.
Interventions
DEVICEGixam System
All participant will undergo the Gixam test per device instructions for use
DIAGNOSTIC_TESTFIT
FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis.
PROCEDUREStandard of care screening colonoscopy
All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study
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. Has completed Cologuard, Sheild, ColoSense or Epi proColon testing 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 anti-inflammatories or 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 study at 30 days after | Number of device-related adverse events and serious adverse events. |
| Primary Efficacy Endpoints | Through study completion, an average of 30 days | Sensitivity and specificity of Gixam in participants with a negative FIT result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmatory Secondary Efficacy Endpoints | Through study completion, an average of 30 days | Standalone sensitivity and specificity of Gixam in general average risk population. |
Countries
United States
Outcome results
None listed