Status:
RECRUITING
Evaluation of Gixam's Performance in a FIT Negative Population
Lead Sponsor:
Jubaan Ltd.
Conditions:
Colorectal Adenoma
Colorectal Cancer (CRC)
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
Brief Summary
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases de...
Eligibility Criteria
Inclusion
- Subjects aged 45-85 years.
- Able to provide a signed informed consent.
- Scheduled for a screening colonoscopy at the investigation site.
Exclusion
- Undergoing diagnostic 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.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
- Subject 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 are 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.
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn\'s disease.
- Subjects with a disability to extend their tongue.
- Subjects with tongue piercing.
- Dental visit in the past 7 days prior to Gixam test.
- Intake of pro-biotics over the past 3 months pre-Gixam test.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06612281
Start Date
November 1 2024
End Date
April 30 2025
Last Update
November 14 2024
Active Locations (1)
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1
The Oregon Clinic Gastroenterology-East
Portland, Oregon, United States, 97220