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Recruiting NCT04022616

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specimen collection.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Interventions

  • Other Specimen collection
    Specimens are obtained from patients who are being treated for breast malignancies.

Primary outcome measures

  • 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. [Time frame: up to 1 year]
Secondary outcome measures (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 [Time frame: 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. [Time frame: 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. [Time frame: up to 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Unable to tolerate venipuncture

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Publications

  • 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 opera PMID 32429929

Identifiers

NCT: NCT04022616 · OSU-09142

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗