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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Brooklyn Methodist Hospital - NewYork Presbyterian, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Carriers of other cancers other than breast.

Treatment and study plan

Live Biobank

Procedure

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.

Primary outcomes

establish a live biobank for breast cancer patients

Time frame: 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 outcomes

assess immune relevant genes from tumor biopsies

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabiana Gregucci, M.D.

CONTACT

[email protected]

646-962-3110

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: DIGNITY

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2028
First posted: Nov 26, 2021
Registry last updated: Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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