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VOCs vs FIT for Colorectal Cancer Screening

NCT04407416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-05-29

No results posted yet for this study

Summary

Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC.

Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality reduction.

Aim of the study To compare the reliability of this breath analysis with Immunochemically-based Fecal Occult Blood Test.

Conditions

Interventions

PROCEDURE

Breath sampling

The breath of all subjects included will be sampled using a device able to capture the alveolar air and to fix it on carbon tubes, Then the tubes will be desorbed and analysed using gas chromatography

Sponsors & Collaborators

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Principal Investigators

  • Elisabetta Martinelli, MD · Societa Italiana di Chirurgia ColoRettale

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-02
Primary Completion
2022-05-02
Completion
2022-05-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04407416 on ClinicalTrials.gov