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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Carcinoma Advanced Adenomas (AA)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy

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

No interventions assigned to this group

Advanced Adenoma

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

No interventions assigned to this group

Colorectal Cancer

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes