Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Carcinoma, Advanced Adenomas (AA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
Overview
This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.
Primary outcome measures
- Clinical Validation [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Patients over the age of 18 who are able to understand the participant information and sign the informed consent.
- Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC).
Exclusion criteria
- Patients who had developed any type of cancer in the 5 years prior to their participation in this study.
- Patients who have received previous chemotherapy or radiotherapy.
- Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome.
- Patients with inadequate bowel preparation for colonoscopy.
- Patients who have undergone colonoscopy/polipectomy in the previous 5 years.
- Patients with hemolyzed plasma.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 9 centers
- Hospital Clinico Universitario Lozano Blesa — Zaragoza
- Hospital Universitario de Cruces — Bilbao
- Policlinica Gipuzkoa Hospital — Donostia / San Sebastian
- Hospital Universitario Marques de Valdecilla — Santander
- Hospital Universitario de Salamanca — Salamanca
- Hospital Sant Rafael — Barcelona
- Hospital Universitario Vall d' Hebron — Barcelona
- MD Anderson Cancer Centre — Madrid
- … and 1 more center
Publications
- Herreros-Villanueva M, Duran-Sanchon S, Martin AC, Perez-Palacios R, Vila-Navarro E, Marcuello M, Diaz-Centeno M, Cubiella J, Diez MS, Bujanda L, Lanas A, Jover R, Hernandez V, Quintero E, Jose Lozano J, Garcia-Cougil M, Martinez-Arranz I, Castells A, Gironella M, Arroyo R. Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer. Clin Transl Gastroenterol. 2019 Jan;10(1):e000 PMID 30702491
- Giraldez MD, Lozano JJ, Ramirez G, Hijona E, Bujanda L, Castells A, Gironella M. Circulating microRNAs as biomarkers of colorectal cancer: results from a genome-wide profiling and validation study. Clin Gastroenterol Hepatol. 2013 Jun;11(6):681-8.e3. doi: 10.1016/j.cgh.2012.12.009. Epub 2012 Dec 23. PMID 23267864
- Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701. PMID 8247072
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
Identifiers
NCT: NCT06889883 · AMD-CCR-2022-02