ACTRN12619000301167
Completed
未知
A prospective, cross-sectional, multi-centre study to evaluate the clinical performance of the ColoSTAT In Vitro Diagnostic for the detection and evaluation of biomarkers associated with the occurrence of colorectal cancer
Vision Tech Bio Pty Ltd0 sites815 target enrollmentStarted: February 27, 2019Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Vision Tech Bio Pty Ltd
- Enrollment
- 815
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Diagnosis
Eligibility Criteria
- Ages
- 40 Years to 84 Years (—)
- Sex
- All
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.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Patients with Type 2 Diabetes Mellitus by using Glycemic HappinessHealth Condition 1: E119- Type 2 diabetes mellitus without complicationsCTRI/2022/09/045216Dr Reddys Laboratories Ltd
Completed
Not Applicable
Comparison of SIRS criteria and qSOFA score for identifying sepsis in the Emergency DepartmentNL-OMON23850none750
Completed
Not Applicable
An observational multicenter study comparing Tenecteplase assisted Percutaneous Coronary Intervention (PCI) versus primary PCI in Indian patients with ST elevation Myocardial InfarctioHealth Condition 1: null- Patients with acute STEMI who are to be treated with primary PCI/pharmacoinvasive therapy within 12 hours of symptoms onset will be included.CTRI/2011/08/001950STEMI India Charitable Trust200
Completed
Phase 4
A prospective, observational, multi-centre study investigating alterations of gut microbiome with its subsequent interaction on the brain-immune-intestine axis in patients with active relapsing remitting Multiple Sclerosis who start with oral treatment.multiple sclerosis10029305NL-OMON54765Sint Elisabeth Ziekenhuis72
Recruiting
Not Applicable
A clinical study to establish a database for evaluation of disease progression in adults patients with chronic kidney diseaseHealth Condition 1: null- Chronic Kidney DiseaseCTRI/2012/06/002743Fresenius Kabi Asia Pacific Ltd2,500