Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

ADVANCED MARKER DISCOVERY S.L.

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT06889844

AMD-CCR-2022-01

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

Cancer or Gastrointestinal Disease

Description:

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.

Treatment:

Diagnostic Test: blood sampling