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

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: Breast Cancer
• Intervention / Treatment: Procedure: Live Biobank

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

• Study Contact: Name: Pragya Yadav, Ph.D.; Phone Number: 646-962-2196; Email: pry2003@med.cornell.edu
• Study Contact Backup: Name: Sharanya Chandrasekhar, M.S.; Phone Number: 646-962-3110; Email: shc2043@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • Recruiting
      • Brooklyn Methodist Hospital - NewYork Presbyterian
      • Contact: Pragya Yadav, Ph.D.; Phone Number: 6469622196; Email: pry2003@med.cornell.edu
      • Principal Investigator: Hani Ashamalla, M.D.
      • Contact: Sharanya Chandrasekhar, M.S.; Phone Number: 646-962-3110; Email: shc2043@med.cornell.edu
    • New York, New York, United States, 11355
      • Recruiting
      • New York Presbyterian Hospital - Queens
      • Contact: Sarah Stankiewicz, B.S.; Phone Number: 718-661-7246; Email: sas9306@nyp.org
      • Sub-Investigator: Akkamma Ravi, M.D.
      • Principal Investigator: Silvia Formenti, M.D.
      • Contact: Sharanya Chandrasekhar, M.S.; Phone Number: 646-962-2196; Email: shc2043@med.cornell.edu

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	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

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

Study record dates

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): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• 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