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

December 9, 2025 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11215
        • Recruiting
        • Brooklyn Methodist Hospital - NewYork Presbyterian
        • Principal Investigator:
          • Hani Ashamalla, M.D.
        • Contact:
      • New York, New York, United States, 11355
        • Recruiting
        • New York Presbyterian Hospital - Queens
        • Sub-Investigator:
          • Akkamma Ravi, M.D.
        • Principal Investigator:
          • Silvia Formenti, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients (BC), any stage irrespective of hormonal status will be eligible for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Silvia Formenti, M.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-06023682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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