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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Pancreatic Cancer
• Intervention / Treatment: Diagnostic test: VOX

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HAREL HERSHTIK; Phone Number: 0546641812; Email: harel.hershtik@gmail.com

Study Locations

• Israel
  • Be'er Ya'aqov, Israel
    • Shamir Medical Center
    • Contact: Haim Shirin, MD; Phone Number: +972505191475; Email: Haimsh@shamir.gov.il
    • Principal Investigator: Haim Shirin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Scentech Medical Technologies Ltd
• Investigators: Principal Investigator: Haim Shirin, MD, Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CRCPC-SMC-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD is to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No