Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer

NCT06889883 | Recruiting

• 1 other identifier: AMD-CCR-2022-02
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 9

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.

Conditions

Colorectal Carcinoma; Advanced Adenomas (AA)

Outcome Measures

Primary Outcomes (1)

• Clinical Validation

  To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors

  36 months

Study Arms (3)

Healthy

Individual with no findings or findings not related to neoplasia on colonoscopy

Advanced Adenoma

Patient diagnosed with advanced adenoma by colonoscopy and confirmed by histology result

Colorectal Cancer

Patient diagnosed with colorectal cancer by colonoscopy and confirmed by histology result

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADVANCED MARKER DISCOVERY S.L.: lead

Study Sites (9)

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

RECRUITING

Hospital Universitario de Cruces

Bilbao, Basque Country, Spain

RECRUITING

Policlinica Gipuzkoa Hospital

Donostia / San Sebastian, Basque Country, Spain

COMPLETED

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

TERMINATED

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

RECRUITING

Hospital Sant Rafael

Barcelona, Catalonia, Spain

COMPLETED

Hospital Universitario Vall d' Hebron

Barcelona, Catalonia, Spain

COMPLETED

MD Anderson Cancer Centre

Madrid, Madrid, Spain

ACTIVE NOT RECRUITING

Hospital Centro Médico de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 30702491 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Marta Jimenez

CONTACT

+34637899149; mjimenez@amadix.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: June 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)