Validation of the Oncoliq Test for the Early Detection of Breast Cancer.

Oncoliq US Inc

Status: Enrolling

Conditions: Breast Cancer With Low to Intermediate HER2 Expression; Breast Cancer Female; Breast Cancer - Female; Breast Cancer - Infiltrating Ductal Carcinoma; Breast Cancer - Ductal Carcinoma in Situ (DCIS); Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer Detection; Breast Cancer (Early Breast Cancer)

Treatments: Other: Peripheral blood draw

Study type: Observational

Funder types: Industry

Identifiers

NCT07331506

DIM001

Details and patient eligibility

About

Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.

MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.

The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.

The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.

Enrollment: 300 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Group 1 - Breast Cancer:

Age between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent

Group 2 - No Cancer (Control):

Age between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent

Exclusion criteria

Refusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer

Trial design

300 participants in 2 patient groups

Breast Cancer Cohort

Description:

Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment.

Treatment:

Other: Peripheral blood draw

Healthy Control Cohort

Description:

Cancer-free volunteers confirmed by breast imaging (BI-RADS 1 or 2) and without a prior history of cancer.

Treatment:

Other: Peripheral blood draw