NCT07894081Not yet recruiting
Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Oct 2026
- Start date
- 2 Nov 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Jubaan Ltd.
- NCT number
- NCT07894081
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 2 Nov 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants that had a dental visit in the 7 days prior to the Gixam test.
- Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
- Participants that have taken probiotics in the 14 days prior to the Gixam test.
Other illness
- History of colorectal cancer.
- 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.
- Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
Age
- Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
Other
- Undergoing colonoscopy for investigation of symptoms.
- 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.
- Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
- Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
- Participants with a disability to extend their tongue.
- Participants with tongue tremor.
- Participants with tongue piercing.
- Participant is pregnant.
Who the study is looking for
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
Age in the registry: 45 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orlando Gastroenterology, PA Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.