Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Cancer
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study.
1 other identifier
interventional
250
1 country
1
Brief Summary
Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started May 2024
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedFebruary 7, 2024
February 1, 2024
9 months
May 24, 2022
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Test Sensitivity and specificity for colorectal polyps.
Through the study completion, up to 1 year.
Test Sensitivity and specificity for pancreatic cancer.
Through the study completion, up to 1 year.
Study Arms (3)
Colorectal Cancer
EXPERIMENTALSubjects who were diagnosed as Colorectal Cancer patients by colonoscopy.
Pancreatic Cancer
EXPERIMENTALSubjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography.
Healthy volunteers
OTHERSubjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Lacks capacity or is unable to provide informed written consent.
- Pregnant or lactating woman.
- Histologically confirmed cancer in any organ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shamir Medical Center
Be’er Ya‘aqov, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haim Shirin, MD
Assaf-Harofeh Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 1, 2022
Study Start
May 1, 2024
Primary Completion
January 30, 2025
Study Completion
March 31, 2025
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
No IPD is to be shared with other researchers.