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

February 6, 2024 updated by: Scentech Medical Technologies Ltd

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel
        • Shamir Medical Center
        • Contact:
        • Principal Investigator:
          • Haim Shirin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
Through the study completion, up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Sensitivity and specificity for colorectal polyps.
Time Frame: Through the study completion, up to 1 year.
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.
Time Frame: Through the study completion, up to 1 year.
Comparison of Volatile Organic Compounds found among pancreatic patients and Healthy controls.
Through the study completion, up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scentech Medical Technologies Ltd

Investigators

  • Principal Investigator: Haim Shirin, MD, Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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