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

Primary Purpose

Colorectal Cancer, Pancreatic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VOX
Sponsored by
Scentech Medical Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shamir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Colorectal Cancer

Pancreatic Cancer

Healthy volunteers

Arm Description

Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy.

Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography.

Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Test Sensitivity and specificity for colorectal polyps.
Comparison of Volatile Organic Compounds found among subjects with and without colorectal polyps.
Test Sensitivity and specificity for pancreatic cancer.
Comparison of Volatile Organic Compounds found among pancreatic patients and Healthy controls.

Full Information

First Posted
May 24, 2022
Last Updated
September 19, 2023
Sponsor
Scentech Medical Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05400408
Brief Title
Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Acronym
Cancer
Official Title
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scentech Medical Technologies Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Pancreatic Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colorectal Cancer
Arm Type
Experimental
Arm Description
Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy.
Arm Title
Pancreatic Cancer
Arm Type
Experimental
Arm Description
Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography.
Intervention Type
Diagnostic Test
Intervention Name(s)
VOX
Intervention Description
Breath Biopsy Analysis
Primary Outcome Measure Information:
Title
identification of Volatile Organic Compounds that can be related to Colorectal malignancy.
Description
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.
Time Frame
Through the study completion, up to 1 year.
Secondary Outcome Measure Information:
Title
Test Sensitivity and specificity for colorectal polyps.
Description
Comparison of Volatile Organic Compounds found among subjects with and without colorectal polyps.
Time Frame
Through the study completion, up to 1 year.
Title
Test Sensitivity and specificity for pancreatic cancer.
Description
Comparison of Volatile Organic Compounds found among pancreatic patients and Healthy controls.
Time Frame
Through the study completion, up to 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAREL HERSHTIK
Phone
0546641812
Email
harel.hershtik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Shirin, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haim Shirin, MD
Phone
+972505191475
Email
Haimsh@shamir.gov.il
First Name & Middle Initial & Last Name & Degree
Haim Shirin, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD is to be shared with other researchers.

Learn more about this trial

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

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