NCT04407416

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 22, 2020

Last Update Submit

May 27, 2020

Conditions

Colorectal CancerColorectal Polyp

Outcome Measures

Primary Outcomes (2)

  • FIT sensitivity

    Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients

    30 days

  • Breath analysis sensitivity

    Evaluate the sensitivity Breath analysis to detect colorectal cancer patients

    30 days

Study Arms (3)

Healthy subjects

ACTIVE COMPARATOR

The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler

Procedure: Breath sampling

Colorectal Cancer patients

ACTIVE COMPARATOR

The breath of all patients with positive FIT (fecal immunochemical test) and a colorectal cancer detected by colonoscopy will be sampled using a breath sampler

Procedure: Breath sampling

Colonic Polyps patients

ACTIVE COMPARATOR

The breath of all patients with positive FIT (fecal immunochemical test) and a colonic polyp detected by colonoscopy will be sampled using a breath sampler

Procedure: Breath sampling

Interventions

Breath samplingPROCEDURE

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

Colonic Polyps patientsColorectal Cancer patientsHealthy subjects

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with and without positive FIT with a planned colonoscopy
  • Patients included in the regional screening program for CRC
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Inflammatory bowel disease
  • Bowel prep
  • Any psychiatric disease
  • Previous (or still present) cancers in other organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Emergency and Organ transplantation

Bari, 70124, Italy

RECRUITING

Related Publications (4)

  • Bond A, Greenwood R, Lewis S, Corfe B, Sarkar S, O'Toole P, Rooney P, Burkitt M, Hold G, Probert C. Volatile organic compounds emitted from faeces as a biomarker for colorectal cancer. Aliment Pharmacol Ther. 2019 Apr;49(8):1005-1012. doi: 10.1111/apt.15140. Epub 2019 Mar 3.

    PMID: 30828825RESULT

  • Altomare DF, Di Lena M, Porcelli F, Trizio L, Travaglio E, Tutino M, Dragonieri S, Memeo V, de Gennaro G. Exhaled volatile organic compounds identify patients with colorectal cancer. Br J Surg. 2013 Jan;100(1):144-50. doi: 10.1002/bjs.8942.

    PMID: 23212621RESULT

  • Stracci F, Zorzi M, Grazzini G. Colorectal cancer screening: tests, strategies, and perspectives. Front Public Health. 2014 Oct 27;2:210. doi: 10.3389/fpubh.2014.00210. eCollection 2014.

    PMID: 25386553RESULT

  • Mousavinezhad M, Majdzadeh R, Akbari Sari A, Delavari A, Mohtasham F. The effectiveness of FOBT vs. FIT: A meta-analysis on colorectal cancer screening test. Med J Islam Repub Iran. 2016 May 9;30:366. eCollection 2016.

    PMID: 27493910RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Elisabetta Martinelli, MD

    Societa Italiana di Chirurgia ColoRettale

    STUDY CHAIR

Central Study Contacts

Donato Altomare, Prof

CONTACT

+393397593066donatofrancesco.altomare@uniba.it

Arcangelo Picciariello, MD

CONTACT

+393492185104arcangelopicciariello@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 29, 2020

Study Start

May 2, 2020

Primary Completion

May 2, 2022

Study Completion

May 30, 2022

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

IT(1)