Clinical trial NCT06889883: Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Carcinoma
Advanced Adenomas (AA)
Lead sponsor: ADVANCED MARKER DISCOVERY S.L.
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves the recruitment of 510 patients as part of a case-control study. Patients who are going to undergo colonoscopy or who are going to undergo surgery for resection of a CRC already diagnosed will be included. They can be symptomatic or asymptomatic, ambulatory, hospitalized or consecutive patients in the Endoscopy Unit.

Brief summary: 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.


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.

Primary outcomes:
measure: Clinical Validation
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
state: Aragon
city: Oviedo
country: Spain
facility: Hospital Centro Médico de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Hospital Sant Rafael
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d' Hebron
state: Cataluña
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
state: Euskadi
city: San Sebastian
country: Spain
facility: Policlinica Gipuzkoa Hospital
state: Euskadi
city: Madrid
country: Spain
facility: MD Anderson Cancer Centre
Study officials:
References:
citation: 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):e00003. doi: 10.14309/ctg.0000000000000003.
citation: 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.
citation: 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.
citation: 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.