Actively Recruiting

Age: 18Years - 70Years
All Genders
ID06315868

Breast Cancer Subtype Characterization Through Patient's Derived Organoids (BCinsightPDO)

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-03-18

306

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating breast cancer, focusing on patients who lack targeted therapies such as those with triple-negative breast cancer or those experiencing relapse after previous treatments. The study aims to develop tools to predict how patients respond to chemotherapy and to identify related biomarkers. Patient-derived organoids (PDOs), which are lab-grown tumor models preserving key tumor features, are being explored as a promising method for personalized treatment development. The study involves creating and maintaining a living biobank of PDOs that represent various breast cancer subtypes, including ER/PR+, HER2+, and triple-negative breast cancer. These PDOs will be used to assess their similarity to original tumor samples and to test their sensitivity to new and existing therapeutic agents, including splicing-targeting treatments and potential combinations with immunotherapies. The research includes both prospective and retrospective analysis over periods of 36 to 42 months. Participants will be women aged 18 to 70 years diagnosed with primary breast cancer and eligible for tumor surgery. The study evaluates the histological and molecular match between PDOs and patient tumors, as well as PDO responses to treatments through laboratory experiments. Researchers will use these findings to understand chemotherapy resistance and explore new treatment options. The overall study participation includes tumor sample collection and laboratory analysis without direct treatment intervention, and it will continue through mid-2027 for comprehensive data collection and analysis.

CONDITIONS

Brief Title

Breast Cancer Subtype Characterization Through Patient's Derived Organoids.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with primary breast cancer eligible for surgical tumor removal
  • Age between 18 and 70 years
  • Newly diagnosed breast tumors with at least 1.5 cm diameter
Not Eligible

You will not qualify if you...

  • Breast cancer diagnosed during pregnancy
  • Prior neoadjuvant chemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sample Collection

Duration - At time of surgery

Participants provide tumor samples during surgical tumor removal to develop patient-derived organoids (PDOs) for breast cancer subtype characterization.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 42 months

Participants’ PDOs are observed over time to evaluate histological and molecular conformity and sensitivity to therapeutic agents, supporting prospective and retrospective studies on breast cancer chemoresistance.

Trial Site Locations

Total: 1 location

1

IRCCS Fondazione Policlinico A. Gemelli

Roma, Italy, 00168

Actively Recruiting

Loading map...

Research Team

A

Alba Di Leone, Doc

C

Chiara Naro, Doc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

Investigating The Role of Key Non-coding RNA(s) in Breast Ca...

Breast Cancer

Actively Recruiting

1 location

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Bre...

Breast Cancer

Actively Recruiting

1 location

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Insights into Molecular Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment.

Ana C Garrido-Castro, Nancy U Lin, Kornelia Polyak

https://pubmed.ncbi.nlm.nih.gov/30679171