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Volatile Organic Compounds (VOCs) Profile in Colorectal Cancer Patients and Healthy Controls.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217083
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Societa Italiana di Chirurgia ColoRettale

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.


Condition or disease Intervention/treatment
Colorectal Cancer Colon Polyp Diagnostic Test: Breath sampling

Detailed Description:

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.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Volatile Organic Compounds (VOCs) Could Discriminate Patients With Colorectal Cancer From Healthy Controls.
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Colorectal cancer patients
Patients with histologically proven Colorectal cancer detected during the colonoscopy
Diagnostic Test: 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
Diagnostic Test: 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




Primary Outcome Measures :
  1. Test Sensitivity and specificity for colorectal cancer [ Time Frame: 30 days ]
    A specificity of 80% and a sensitivity of 90% will be considered reliable


Secondary Outcome Measures :
  1. Test Sensitivity and specificity for colorectal polyps [ Time Frame: 30 days ]
    A specificity of 80% and a sensitivity of 90% will be considered reliable



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients which will be consulted at the Tertiary center of colorectal surgery (Policlinico of Bari)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217083


Contacts
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Contact: Donato Altomare, Prof +393397593066 donatofrancesco.altomare@uniba.it
Contact: Arcangelo Picciariello, MD +393492185104 arcangelopicciariello@gmail.com

Locations
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Italy
Dept of Emergency and Organ transplantation - University of Bari Recruiting
Bari, Italy, 70124
Contact: Donato F Altomare, Prof       donatofrancesco.altomare@uniba.it   
Principal Investigator: Donato Altomare, MD         
Principal Investigator: Arcangelo Picciariello, MD         
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
Investigators
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Principal Investigator: Donato Altomare, Prof Societa Italiana di Chirurgia ColoRettale
Publications of Results:
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Responsible Party: Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier: NCT04217083    
Other Study ID Numbers: 141/2019
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases