Skip to main content
Clinical Trials/NCT05317221
NCT05317221
Recruiting
Not Applicable

Developing Breast (Cancer) Organoids

Maastricht Radiation Oncology1 site in 1 country60 target enrollmentSeptember 1, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Maastricht Radiation Oncology
Enrollment
60
Locations
1
Primary Endpoint
Living biobank
Status
Recruiting
Last Updated
12 months ago

Overview

Brief Summary

Currently, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. Therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. Organoids are patient-derived aggregates that grow in 3D and maintain self- renewal pluripotency and lineage-specific differentiation. Therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening.

This now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes.

Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are:

  1. Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?
  2. Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?
  3. Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?
  4. Can BC organoids be used to discover mechanisms of treatment resistance and relapse?

Detailed Description

The investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. Patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (WES) to compare the genetic profile of the patients with the organoids and the patient biopsy. The patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour. Patient will undergo standard diagnostic procedures and treatment according to the Dutch breast cancer surgery guidelines. After surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. This material will then be used to develop breast cancer organoids. As part of the routine surgical procedure, 6 ml of blood will be collected. Participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. Therefore, participation does not change the patient's treatment or outcome.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
May 1, 2028
Last Updated
12 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Maastricht Radiation Oncology
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \>18 years,
  • Family Anamneses
  • Breast cancer (proven by histopathology), Included subtypes; (ER-,PR- HER2-); (ER+, PR+, HER2-); (ER+, PR+ HER2+).
  • Primary surgery (lumpectomy or mastectomy)

Exclusion Criteria

  • Physically or mentally incapable or incompetent to sign informed consent

Outcomes

Primary Outcomes

Living biobank

Time Frame: 12 months

The development of a patient derived breast cancer living biobank using 3D organoid technology reflecting the most prominent clinical subtypes.

Secondary Outcomes

  • Organoids.(12 months)

Study Sites (1)

Loading locations...

Similar Trials