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NCT07718841

neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer

Sponsor: Spanish Breast Cancer Research Group

View on ClinicalTrials.gov

Summary

The goal of this observational study is to explore the utility of analytical techniques that enable the study of small amounts of tumor-derived material circulating in the blood, such as fragments of circulating tumor DNA (also known as ctDNA), cells, or other particles. This type of sample is generally referred to as a liquid biopsy, and its analysis is a minimally invasive test, as it only requires the collection of blood samples. The study includes women and men with early-stage breast cancer (EBC) who are about to start neoadjuvant treatment (treatment given before surgery). The main questions it aims to answer are: * Can liquid biopsy analyses (ctDNA) provide additional information about the type of tumor before treatment starts? * Can these analyses help to detect early whether the tumor is responding to treatment? * Can these tests identify if any cancer remains after neoadjuvant treatment or after surgery? * Is this information related to the risk of the cancer coming back? * Can these analyses, when performed during follow-up, help detect cancer recurrence earlier? Participants will: * Continue receiving standard medical care for their breast cancer, including neoadjuvant therapy and surgery. * Provide blood samples at different time points during treatment and follow-up. * Provide residual tumor samples from the routine clinical care.

Official title: neoAGORA: A Prospective Observational Study to Explore the Clinical Utility of Serial Liquid Biopsy in Patients With Early-stage Breast Cancer Receiving Neoadjuvant Therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-08

Completion Date

2033-08

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

OTHER

biological samples, images, and clinical data

This is an observational study in which clinical decisions concerning the optimum therapy for a particular patient are taken independently of, and prior to, offering the patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. The study will systematically collect and integrate biological samples, images, and clinical data in the neoadjuvant and follow-up period. Serial blood samples are collected for neoAGORA study align with blood extractions performed as part of the patient's standard clinical care and tumor samples are residual samples from clinical practice.

Locations (10)

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Hospital Clínico Universitario San Carlos

Madrid, Madrid, Spain

Hospital Clínico Universitario Virgen De la Victoria

Málaga, Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Universitario de Toledo

Toledo, Toledo, Spain

Instituto Valenciano de Oncologia

Valencia, Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain