NCT04217083

Brief Summary

Volatile organic compounds (VOCs) are low molecular weight (\<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer. Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. The expression of VOCs in breath that are linked to a patient's disease state could offers a powerful, non-invasive approach to identifying CRC patients.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

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

January 2, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 29, 2019

Last Update Submit

December 31, 2019

Conditions

Colorectal CancerColon Polyp

Outcome Measures

Primary Outcomes (1)

  • Test Sensitivity and specificity for colorectal cancer

    A specificity of 80% and a sensitivity of 90% will be considered reliable

    30 days

Secondary Outcomes (1)

  • Test Sensitivity and specificity for colorectal polyps

    30 days

Study Arms (2)

Colorectal cancer patients

Patients with histologically proven Colorectal cancer detected during the colonoscopy

Diagnostic Test: Breath sampling

healthy controls

Patients with no sign of any colorectal disease who are submitted to colonoscopy

Diagnostic Test: Breath sampling

Interventions

Breath samplingDIAGNOSTIC_TEST

The alveolar fraction of Colorectal cancer patients and Healthy controls will be sampled using a breath sampler able to fix the volatile organic compound on absorbable tubes

Colorectal cancer patientshealthy controls

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients which will be consulted at the Tertiary center of colorectal surgery (Policlinico of Bari)

You may qualify if:

  • Age between 18 and 95
  • Histologically proven colorectal cancer
  • Patient with single or multiple polyps of the colon
  • Healthy subjects with negative colonoscopy
  • Patients already sampled and operated for colorectal cancer with no sign of recurrence
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Inflammatory bowel disease
  • Synchronous cancers
  • Liver and/or lung metastasis
  • Bowel prep
  • Recurrent CRC
  • Any psychiatric disease
  • Emergency operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Emergency and Organ transplantation - University of Bari

Bari, 70124, Italy

RECRUITING

Related Publications (4)

  • Fuchs P, Loeseken C, Schubert JK, Miekisch W. Breath gas aldehydes as biomarkers of lung cancer. Int J Cancer. 2010 Jun 1;126(11):2663-70. doi: 10.1002/ijc.24970.

    PMID: 19839051RESULT

  • 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

  • Arasaradnam RP, McFarlane MJ, Ryan-Fisher C, Westenbrink E, Hodges P, Thomas MG, Chambers S, O'Connell N, Bailey C, Harmston C, Nwokolo CU, Bardhan KD, Covington JA. Detection of colorectal cancer (CRC) by urinary volatile organic compound analysis. PLoS One. 2014 Sep 30;9(9):e108750. doi: 10.1371/journal.pone.0108750. eCollection 2014.

    PMID: 25268885RESULT

  • 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

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Donato Altomare, Prof

    Societa Italiana di Chirurgia ColoRettale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donato Altomare, Prof

CONTACT

+393397593066donatofrancesco.altomare@uniba.it

Arcangelo Picciariello, MD

CONTACT

+393492185104arcangelopicciariello@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 3, 2020

Study Start

January 2, 2019

Primary Completion

December 25, 2020

Study Completion

January 20, 2021

Last Updated

January 3, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)