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

Breast Cancer Clinical Trial

— DIGNITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134779
• Other study ID #: 21-06023682
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Weill Medical College of Cornell University
• Contact: Sharanya Chandrasekhar, M.S.
• Phone: 646-962-3110
• Email: shc2043[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Carriers of other cancers other than breast.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Brooklyn Methodist Hospital - NewYork Presbyterian	New York	New York
United States	New York Presbyterian Hospital - Queens	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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