Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Study analyzes immune cells in breast cancer patients to understand treatment response.
Plain English Summary
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients is a Not Applicable clinical trial sponsored by Ohio State University Comprehensive Cancer Center studying Breast Cancer. This study looks at specific immune cells called MDSCs in breast cancer patients to see how they affect the body's ability to fight cancer. It is for adults (18+) diagnosed with early to mid-stage breast cancer (Stage I-III). Participation involves providing blood or tumor samples for analysis. There are no alternative treatments being tested in this study; it is observational. The trial aims to enroll 99 participants.
Official Summary
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older with Stage I, II, or III breast cancer can join. You must be able to understand and agree to participate in the study. Individuals who cannot tolerate having blood drawn will not be able to participate. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure how well specific immune cells (MDSCs) can block the body's cancer-fighting immune cells, which helps researchers understand how the cancer might be evading the immune system. The specific primary outcome measures are: 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. (up to 1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because understanding how certain immune cells affect cancer can lead to better ways to treat breast cancer in the future. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This observational study provides insights into the tumor microenvironment, a key area of research for developing new cancer immunotherapies, potentially impacting a significant market for breast canc
Is This Trial Right for Me?
Ask your doctor if your breast cancer stage and treatment plan make you eligible for this study. You will need to provide blood samples, and potentially tumor tissue, for analysis. The study involves regular sample collection over a period of up to one year. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 99 participants
Interventions
- OTHER: Specimen collection — Specimens are obtained from patients who are being treated for breast malignancies.
Primary Outcomes
- 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. (up to 1 year)
Secondary Outcomes
- 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)
Full 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
Trial Locations
- Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Frequently Asked Questions
What is clinical trial NCT04022616?
NCT04022616 is a Not Applicable OBSERVATIONAL study titled "Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients." It is currently recruiting and is sponsored by Ohio State University Comprehensive Cancer Center. The trial targets enrollment of 99 participants.
What conditions does NCT04022616 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT04022616?
The interventions being studied include: Specimen collection (OTHER). Specimens are obtained from patients who are being treated for breast malignancies.
What does Not Applicable mean for NCT04022616?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04022616?
This trial is currently "Recruiting." It started on 2010-06-04. The estimated completion date is 2027-12-31.
Who is sponsoring NCT04022616?
NCT04022616 is sponsored by Ohio State University Comprehensive Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04022616?
The trial aims to enroll 99 participants. The trial is currently recruiting and accepting new participants.
How is NCT04022616 designed?
This is a observational study.
What are the primary outcomes being measured in NCT04022616?
The primary outcome measures are: 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. (up to 1 year). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04022616 being conducted?
This trial is being conducted at 1 site, including Columbus, Ohio (United States).
Where can I find official information about NCT04022616?
The official record for NCT04022616 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04022616. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04022616 testing in simple terms?
This study looks at specific immune cells called MDSCs in breast cancer patients to see how they affect the body's ability to fight cancer. It is for adults (18+) diagnosed with early to mid-stage breast cancer (Stage I-III).
Why is this trial significant?
This trial is important because understanding how certain immune cells affect cancer can lead to better ways to treat breast cancer in the future.
What are the potential risks of participating in NCT04022616?
The main risk is discomfort or bruising from blood draws. There is a small risk of infection at the site of blood collection. Potential for emotional distress related to cancer diagnosis and study procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04022616?
Ask your doctor if your breast cancer stage and treatment plan make you eligible for this study. You will need to provide blood samples, and potentially tumor tissue, for analysis. The study involves regular sample collection over a period of up to one year. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04022616 signal from an investment perspective?
This observational study provides insights into the tumor microenvironment, a key area of research for developing new cancer immunotherapies, potentially impacting a significant market for breast canc This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood or tumor samples for analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.