De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Live Biobank

• Registration Number: NCT05134779
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This is a live biobank study for breast cancer (BC) patients where samples will be collected at inflection points in the course of the disease.

Detailed Description

To test this hypothesis the investigators will focus on studying BC patients using an innovative approach, the DIGNITY Study (De-convoluting interactions between genes, the cancer environment, and the immune system to develop therapies that work for you) designed to building a live tissue biobank of Patient Derived Tumor Organoids (PDOs) derived from tumor at surgery, preceded or not by neoadjuvant therapy (NAT), and at recurrence/metastasis. BC patients enrolled in this study are consented to enable investigators to generate a biobank of tumor tissue (obtained from surgically removed excess that would otherwise be disposed off ) and matched blood cells ( obtained from an already existing line or a venipuncture ordered per standard of care testing) at key timepoints in their treatment course.

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-11-26
• Study Start: 2022-01-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• All patients will historically proven BC are eligible to be on the study

Exclusion Criteria

• Carriers of other cancers other than breast.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Live Biobank	Patients with breast cancer (BC), any stage will be considered for this study.

Primary Outcome Measures

Name	Time	Method
establish a live biobank for breast cancer patients	60 months	Tumor tissue will be obtained at key inflection points from breast cancer patients (BC): at initial diagnosis, at surgery and at metastasis or recurrence.; Patient Derived Organoids (PDOs) will be prepared from tumors that are obtained from the BC patients.

Secondary Outcome Measures

Name	Time	Method
assess immune relevant genes from tumor biopsies	60 months	comprehensively characterize the tumor from the biospecimen to determine the mutations, expression of immune related genes, and the quality and the spatial distribution of the immune infiltrate

Trial Locations

Locations (2)

Brooklyn Methodist Hospital - NewYork Presbyterian; 🇺🇸 New York, New York, United States

New York Presbyterian Hospital - Queens; 🇺🇸 New York, New York, United States