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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04022616
Other study ID # OSU-09142
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 4, 2010
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact Ohio State Comprehensive Cancer Center
Phone 1-800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients


Recruitment information / eligibility

Status Recruiting
Enrollment 99
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Ability to give informed consent - Stage I-III breast malignancy Exclusion Criteria: - Unable to tolerate venipuncture

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy. up to 1 year
Secondary 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. Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy. up to 1 year
Secondary Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present. Isolate a lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present. Natural Killer cells are immune cells that are capable of killing cancer cells. up to 1 year
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