NCT05134779

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Live Biobank	Tumor tissue will be collected from consented patients at sequential inflection points in the disease course: at the time of initial diagnosis, at the time of surgery and during recurrence or metastasis. In addition to this, 40ml of research bloods will also be collected at these key inflection points.

Timeline

• Start date: 2022-01-12
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2021-11-26
• Last updated: 2025-12-18

Locations

2 sites across 1 country: United States