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


2024-05-01


2025-01-30


2025-03-31


250

Study Overview

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

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

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.

  • Colorectal Cancer
  • Pancreatic Cancer
  • DIAGNOSTIC_TEST: VOX
  • CRCPC-SMC-2021

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 Registration Dates Results Reporting Dates Study Record Updates

2022-05-24  

N/A  

2024-02-06  

2022-05-26  

N/A  

2024-02-07  

2022-06-01  

N/A  

2024-02  

Study Plan

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

Design Details

Primary Purpose:
Diagnostic


Allocation:
Non Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime 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 MeasuresMeasure DescriptionTime 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.

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

Name: HAREL HERSHTIK

Phone Number: 0546641812

Email: harel.hershtik@gmail.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    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.

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Haim Shirin, MD, Assaf-Harofeh Medical Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available