Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

NCT06889844 | Recruiting

• 1 other identifier: AMD-CCR-2022-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• False Positive Rate

  To estimate the false positive rate of the blood-based test in the main population of the study

  36 month

Study Arms (1)

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

Interventions

blood sampling DIAGNOSTIC_TEST

Patients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study.

Cancer or Gastrointestinal Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADVANCED MARKER DISCOVERY S.L.: lead

Study Sites (5)

Hospitales HM de Malaga

Málaga, Andalusia, Spain

RECRUITING

Hospital Centro Médico Asturias

Oviedo, Cantabria, Spain

RECRUITING

Hospital Universitario de Ourense

Ourense, Galicia, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Spain

RECRUITING

MD Anderson Cancer Centre

Madrid, Madrid, Spain

ACTIVE NOT RECRUITING

Related Publications (3)

• 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.

  PMID: 36856579 BACKGROUND

• 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

• 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

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Marta Jimenez

CONTACT

+34637899149; mjimenez@amadix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)