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

ADVANCED MARKER DISCOVERY S.L.

Status: Enrolling

Conditions: Colorectal Carcinoma; Advanced Adenomas (AA)

Study type: Observational

Funder types: Industry

Identifiers

NCT06889883

AMD-CCR-2022-02

Details and patient eligibility

About

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.

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

510 participants in 3 patient groups

Healthy

Description:

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

Advanced Adenoma

Description:

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

Colorectal Cancer

Description:

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