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

Colorectal Cancer Clinical Trial

— Cancer  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05400408
• Other study ID #: CRCPC-SMC-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Scentech Medical Technologies Ltd
• Contact: HAREL HERSHTIK
• Phone: 0546641812
• Email: harel.hershtik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 31, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• VOX
Breath Biopsy Analysis

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Scentech Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.