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

NCT ID: NCT05134779

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients with breast cancer (BC), any stage will be considered for this study.

Live Biobank

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Carriers of other cancers other than breast.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Formenti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States

Site Status RECRUITING

New York Presbyterian Hospital - Queens

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fabiana Gregucci, M.D.

Role: CONTACT

Phone: 646-962-3110

Email: [email protected]

Facility Contacts

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Izael Niño, M.S.

Role: primary

Hina Ali, M.D.

Role: primary

Other Identifiers

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21-06023682

Identifier Type: -

Identifier Source: org_study_id