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Clinical Trials/NCT06889844
NCT06889844RecruitingNot Applicable

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

ADVANCED MARKER DISCOVERY S.L.5 sites in 1 country250 target enrollmentStarted: April 17, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
250
Locations
5
Primary Endpoint
False Positive Rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

False Positive Rate

Time Frame: 36 month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
ADVANCED MARKER DISCOVERY S.L.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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