Volatile Organic Compounds (VOCs) Profile in Colorectal Cancer Patients and Healthy Controls.
NCT ID: NCT04217083
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
90 participants
OBSERVATIONAL
2019-01-02
2021-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
VOCs vs FIT for Colorectal Cancer Screening
NCT04407416
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
NCT06452745
A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients
NCT06326879
Early Diagnosis and Recurrence Monitoring of Colorectal Cancer
NCT06991452
Volatiles in Breath and Headspace Analysis - Diagnostic Markers
NCT03228095
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Endogenous breath VOCs can originate anywhere in the body, reversed in the venous blood stream and than to the lung alveoli where some of them are exhaled .
Alteration in VOC production in patients with cancer has been postulated to relate to (per)oxygenation of cell membrane-based polyunsaturated fatty acids resulting from genetic and/or protein mutations within tumour cells and the increased relative prevalence of reactive oxygen species within cancer cells. VOCs consist largely of benzene, alkanes and aldehydes (or their derivatives), and several studies have demonstrated that various cancers, including lung and breast cancer,melanoma, mesothelioma and hepatocellular carcinoma, are associated with specific VOC profiles that differ from normal.
Volatile organic compounds are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening.
Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. It is the second leading cause of cancer-related death in Europe and the third in the USA.
Colonoscopy is the gold standard for the diagnosis of CRC, although its cost prevents its use for mass screening. Furthermore colonoscopy is not well accepted by patients since it is an invasive exam. Faecal immunochemical blood testing (FIT) is the most widely used noninvasive screening tool, showing fairly good specificity but a high variation in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the target population.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Colorectal cancer patients
Patients with histologically proven Colorectal cancer detected during the colonoscopy
Breath sampling
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
healthy controls
Patients with no sign of any colorectal disease who are submitted to colonoscopy
Breath sampling
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breath sampling
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Inflammatory bowel disease
* Synchronous cancers
* Liver and/or lung metastasis
* Bowel prep
* Recurrent CRC
* Any psychiatric disease
* Emergency operations
18 Years
95 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Societa Italiana di Chirurgia ColoRettale
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donato Altomare, Prof
Role: PRINCIPAL_INVESTIGATOR
Societa Italiana di Chirurgia ColoRettale
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept of Emergency and Organ transplantation - University of Bari
Bari, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
141/2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.