Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools

The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is

Does the blood test have a low false positive rate in the main study population?

Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: blood sampling

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Marta Jimenez; Phone Number: +34637899149; Email: mjimenez@amadix.com

Study Locations

• Spain
  • Andalusia
    • Málaga, Andalusia, Spain
      • Recruiting
      • Hospitales HM de Malaga
  • Cantabria
    • Oviedo, Cantabria, Spain
      • Recruiting
      • Hospital Centro Médico Asturias
  • Galicia
    • Ourense, Galicia, Spain
      • Recruiting
      • Hospital Universitario de Ourense
  • Madrid
    • Madrid, Madrid, Spain
      • Active, not recruiting
      • Md Anderson Cancer Centre
    • Madrid, Madrid, Spain
      • Recruiting
      • Hospital Universitario HM Sanchinarro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled with a only one diagnosis of cancer (no colorectal cancer) or gastrointestinal disease at the time of a consultation within the Oncology, Digestive System, Gastroenterology, Endoscopy or Surgery Service. Patients will be included in a competitive, consecutive and progressive manner by the Centers.

Description

Inclusion Criteria:

• Patients older than 18 years of age at the time of blood sample collection.
• Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
• Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.

Exclusion Criteria:

• Patients who have received previous chemotherapy or radiotherapy.
• In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
• Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
• Patients without appropriate staging or diagnosis.
• Patients with hemolyzed plasma.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer or Gastrointestinal Disease; A different types of cancer and gastrointestinal disease will be included in the cohort such as breast cancer, bladder cancer, IBDs, Leukemia and Lung cancer.	Diagnostic test: blood sampling; Patients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False Positive Rate	To estimate the false positive rate of the blood-based test in the main population of the study	36 month

Collaborators and Investigators

• Sponsor: ADVANCED MARKER DISCOVERY S.L.

Publications and helpful links

General Publications

• 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.
• Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: AMD-CCR-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No