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RecruitingObservational

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

NCT ID: NCT05134779Sponsor: Weill Medical College of Cornell UniversityLast updated: 2025-12-18

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.

Arms & 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.

Outcome measures

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.

    Time frame: 60 months

Secondary

  • assess immune relevant genes from tumor biopsies

    Time frame: 60 months

Eligibility criteria

Sex: FemaleAge: 18 Years to 90 YearsHealthy 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.

Study locations (2)

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, 11215

Recruiting
Izael Niño, M.S. · Contact
Hani Ashamalla, M.D. · Principal Investigator

New York Presbyterian Hospital - Queens

New York, New York, 11355

Recruiting
Hina Ali, M.D. · Contact
Akkamma Ravi, M.D. · Sub Investigator
Silvia Formenti, M.D. · Principal Investigator
De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You | Cancerify