Evaluation of the Clinical Performance of the ColoSTAT Diagnostic for colorectal cancer biomarkers

Not Applicable

Completed

• Conditions: Early detection of colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12619000301167
• Lead Sponsor: Vision Tech Bio Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Study Completion: 2021-09-01
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 815

Inclusion Criteria

For Cohort 1:
•Participant is diagnosed colonoscopically with colorectal cancer and is progressing to colorectal surgery or neoadjuvant chemo- or radiation therapy within 30 days of enrolment.
•Participant is able to comprehend, sign, and date the written informed consent document to participate in the study.
•Participant is able and willing to be accessible for blood draw prior to surgery.
•Participant is able and willing to provide stool samples according to written instructions provided to them.

For Cohort 2:
•Participant is scheduled to undergo a colonoscopy within 90 days of enrolment.
•Participant is able to comprehend, sign, and date the written informed consent document to participate in the study.
•Participant is able and willing to be accessible for blood draw prior to start of bowel preparation for colonoscopy.
•Participant is able and willing to provide stool samples according to written instructions provided to them.

Exclusion Criteria

For Cohort 1:
•Participant has any condition which, in the opinion of the investigator should preclude participation in the study.
•Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups.

For Cohort 2:
•Participant has any condition which, in the opinion of the investigator should preclude participation in the study.
•Participant has a history of aerodigestive tract cancer.
•Participant has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
•Participant has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding).
•Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups.

Study & Design

• Study Type: Interventional
• Study Design: Not specified