Colorectal Cancer Clinical Trial
Official title:
The Effectiveness of Breath Analysis Versus FIT for Colorectal Cancer Screening
NCT number | NCT04407416 |
Other study ID # | 27/2020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2020 |
Est. completion date | May 30, 2022 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | May 30, 2022 |
Est. primary completion date | May 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients with and without positive FIT with a planned colonoscopy - Patients included in the regional screening program for CRC - Written informed consent Exclusion Criteria: - Pregnancy - Inflammatory bowel disease - Bowel prep - Any psychiatric disease - Previous (or still present) cancers in other organs |
Country | Name | City | State |
---|---|---|---|
Italy | Dept of Emergency and Organ transplantation | Bari |
Lead Sponsor | Collaborator |
---|---|
Societa Italiana di Chirurgia ColoRettale |
Italy,
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. — View Citation
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.151 — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FIT sensitivity | Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients | 30 days | |
Primary | Breath analysis sensitivity | Evaluate the sensitivity Breath analysis to detect colorectal cancer patients | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |