Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

assess immune relevant genes from tumor biopsies
60 months

Study Arms (1)

Cohort 1

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

Procedure: Live Biobank

Interventions

Live BiobankProcedure

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.

Cohort 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

Weill Medical College of Cornell University
Otherlead

Study Sites (2)

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, 11215, United States

RECRUITING

Izael Niño, M.S.CONTACT929-470-9426 izn4001@med.cornell.edu

Hani Ashamalla, M.D.PRINCIPAL INVESTIGATOR

New York Presbyterian Hospital - Queens

New York, New York, 11355, United States

RECRUITING

Hina Ali, M.D.CONTACT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Silvia Formenti, M.D.
Weill Medical College of Cornell University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci, M.D.

CONTACT

646-962-3110 fgr4002@med.cornell.edu

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 26, 2021

Study Start

January 12, 2022

Actual (reported)

Primary Completion

December 31, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Cohort 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Cohort 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations