## Protocol Section
### Identification Module
**NCT ID:** NCT05134779

**Acronym:** DIGNITY

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

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

#### Organization Study ID Info
**ID:** 21-06023682
#### Organization
**Class:** OTHER
**Full Name:** Weill Medical College of Cornell University
### Status Module
#### Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-01-12

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2021-11-26
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-04
**Study First Submit QC Date:** 2021-11-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Weill Medical College of Cornell University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Cancer

### Design Module

#### Bio Spec

**Description:** Tissue collection through the DIGNITY trial will allow the investigators to study the individual tumor and its microenvironment from a biopsy specimen at sequential inflection points and to perform functional genomics experiments using the PDOs technology to determine if the cancer cells can be reprogrammed using radiotherapy and other interventions. Paired blood samples from the patients at each time point will be collected to study circulating cytokines/chemokines, tumor-specific T cells, and innate immune cell response to the PDO.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Live Biobank

**Label:** Cohort 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1

**Description:** 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.

**Name:** Live Biobank

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** establish a live biobank for breast cancer patients

**Time Frame:** 60 months

#### Secondary Outcomes

**Description:** 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

**Measure:** assess immune relevant genes from tumor biopsies

**Time Frame:** 60 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Carriers of other cancers other than breast.

**Gender Based:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** breast cancer patients (BC), any stage irrespective of hormonal status will be eligible for this study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shc2043@med.cornell.edu

**Name:** Sharanya Chandrasekhar, M.S.

**Phone:** 646-962-3110

**Role:** CONTACT

**Contact 2:**

**Email:** pry2003@med.cornell.edu

**Name:** Pragya Yadav, Ph.D.

**Phone:** 646-962-2196

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** shc2043@med.cornell.edu

- **Name:** Sharanya Chandrasekhar, M.S.

- **Phone:** 646-962-3110

- **Role:** CONTACT

***Contact 2:***

- **Email:** pry2003@med.cornell.edu

- **Name:** Pragya Yadav, Ph.D.

- **Phone:** 6469622196

- **Role:** CONTACT

***Contact 3:***

- **Name:** Hani Ashamalla, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Brooklyn Methodist Hospital - NewYork Presbyterian

**State:** New York

**Status:** RECRUITING

**Zip:** 11215

**Location 2:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** sas9306@nyp.org

- **Name:** Sarah Stankiewicz, B.S.

- **Phone:** 718-661-7246

- **Role:** CONTACT

***Contact 2:***

- **Email:** shc2043@med.cornell.edu

- **Name:** Sharanya Chandrasekhar, M.S.

- **Phone:** 646-962-2196

- **Role:** CONTACT

***Contact 3:***

- **Name:** Akkamma Ravi, M.D.

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Silvia Formenti, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** New York Presbyterian Hospital - Queens

**State:** New York

**Status:** RECRUITING

**Zip:** 11355

#### Overall Officials

**Official 1:**

**Affiliation:** Weill Medical College of Cornell University

**Name:** Silvia Formenti, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
