Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05134779
Acronym
DIGNITY
Enrollment
400
Registered
2021-11-26
Start date
2022-01-12
Completion date
2028-12-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

PROCEDURELive 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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Carriers of other cancers other than breast.

Design outcomes

Primary

MeasureTime frameDescription
establish a live biobank for breast cancer patients60 monthsTumor 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

MeasureTime frameDescription
assess immune relevant genes from tumor biopsies60 monthscomprehensively 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

Countries

United States

Contacts

Primary ContactFabiana Gregucci, M.D.
fgr4002@med.cornell.edu646-962-3110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026