Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

NCT04022616 | Recruiting

• 1 other identifier: OSU-09142
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.

  Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies. isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood or the tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells. Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies.

  up to 1 year

Secondary Outcomes (3)

• Isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood of study subjects who plan to start pre-operative chemotherapy for breast cancer to see if MDSC levels can predict who will respond to treatment. W

  up to 1 year

• Isolate unfavorable immune cells MDSC from peripheral blood of study subjects who receive pre-operative chemotherapy for breast cancer to identify changes in MDSC levels during treatment can predict who will respond to treatment.

  up to 1 year

• Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.

  up to 1 year

Study Arms (4)

Immediate Surgery

Adult patients with breast malignancy.

Other: Specimen collection

Neo-adjuvant Chemotherapy

Adult patients with biopsy proven operable breast cancer who in the opinion of treating physician are suited to receive neo-adjuvant chemotherapy.

Other: Specimen collection

Lymph Node Tissue

Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.

Other: Specimen collection

Metastatic Breast Cancer

Adult patients with biopsy proven stage IV breast cancer who are starting a new line palliative systemic therapy. A palliative systemic therapy will be defined in this trial as any chemotherapy regimen or combination of endocrine therapy with targeted agents such as cyclin dependent kinase 4/6 (CDK 4/6) inhibitors, HER2 targeting agents or inhibitors of mammalian target of rapamycin (mTOR).

Other: Specimen collection

Interventions

Specimen collection OTHER

Specimens are obtained from patients who are being treated for breast malignancies.

Immediate Surgery; Lymph Node Tissue; Metastatic Breast Cancer; Neo-adjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are being treated at the Ohio State Comprehensive Cancer Center and Stefanie Spielman Comprehensive Breast Center

You may qualify if:

• years of age or older
• Ability to give informed consent
• Stage I-III breast malignancy

You may not qualify if:

• Unable to tolerate venipuncture

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• Wesolowski R, Stiff A, Quiroga D, McQuinn C, Li Z, Nitta H, Savardekar H, Benner B, Ramaswamy B, Lustberg M, Layman RM, Macrae E, Kassem M, Williams N, Sardesai S, VanDeusen J, Stover D, Cherian M, Mace TA, Yu L, Duggan M, Carson WE 3rd. Exploratory analysis of immune checkpoint receptor expression by circulating T cells and tumor specimens in patients receiving neo-adjuvant chemotherapy for operable breast cancer. BMC Cancer. 2020 May 19;20(1):445. doi: 10.1186/s12885-020-06949-4.

  PMID: 32429929 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• William Carson, MD

  Ohio State Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohio State Comprehensive Cancer Center

CONTACT

1-800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: July 17, 2019
• Study Start: June 4, 2010
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)