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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer; Pancreatic Cancer
• Interventions: Diagnostic Test: VOX

• Registration Number: NCT05400408
• Lead Sponsor: Scentech Medical Technologies Ltd

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Study Start: 2024-05-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer	VOX	Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy.
Pancreatic Cancer	VOX	Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography.
Healthy volunteers	VOX	Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography.

Primary Outcome Measures

Name	Time	Method
identification of Volatile Organic Compounds that can be related to Colorectal malignancy.	Through the study completion, up to 1 year.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel