Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study

Study Overview
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Brief Summary
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Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study

Detailed Description
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A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.

Official Title
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Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.

Conditions
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Colorectal Cancer, Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: VOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 85 years at the time of consent. Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography. Fasted >6 hours, consuming water only. Able to provide informed written consent. Exclusion Criteria: Lacks capacity or is unable to provide informed written consent. Pregnant or lactating woman. Histologically confirmed cancer in any organ.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colorectal Cancer<br>Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy. | Diagnostic Test: VOX<br>* Breath Biopsy Analysis<br>|
| Experimental: Pancreatic Cancer<br>Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography. | Diagnostic Test: VOX<br>* Breath Biopsy Analysis<br>|
| Other: Healthy volunteers<br>Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography. | Diagnostic Test: VOX<br>* Breath Biopsy Analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of Volatile Organic Compounds that can be related to Colorectal malignancy. | Comparison of identity and concentration of Volatile Organic Compounds profile found among colorectal patients and the identity and concentration of Volatile Organic Compounds profile found among Healthy controls. | Through the study completion, up to 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Sensitivity and specificity for colorectal polyps. | Comparison of Volatile Organic Compounds found among subjects with and without colorectal polyps. | Through the study completion, up to 1 year. | 
| Test Sensitivity and specificity for pancreatic cancer. | Comparison of Volatile Organic Compounds found among pancreatic patients and Healthy controls. | Through the study completion, up to 1 year. |