The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer
Study Overview
Detailed Description
Compared to normal tissues, tumor tissues exhibit significant metabolic changes. Consequently, tumor metabolic dysregulation is recognized as a novel marker of cancer. Differential analysis of metabolic phenotypes has the potential to establish new patient stratification criteria and biomarkers that facilitate personalized therapy. Breast cancer is the most prevalent malignant tumor among women. With advancements in metabolomics sequencing technology, an increasing number of researchers are focusing on the role of metabolomics in the diagnosis and treatment of breast cancer. It is important to note that the significance of individual metabolites in relation to breast cancer varies across studies; therefore, a standardized metabolic profile for assessing breast cancer risk has yet to be established.
This project collected data from natural populations and breast cancer patients by analyzing plasma metabolites alongside clinical treatment information. The goals of this study are to explore the correlation between plasma metabolites and breast cancer, as well as to identify biomarkers that characterize therapeutic efficacy and prognosis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Liu Hua, Ph. D
- Phone Number: 15140067366
- Email: 20242027@cmu.edu.cn
Study Contact Backup
- Name: Liu Cai Gang, Ph. D
- Phone Number: 15140067366
- Email: 20242027@cmu.edu.cn
Study Locations
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Liaoning
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Shenyang, Liaoning, China, 110004
- Recruiting
- Shengjing Hospital Of China Medical University
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Contact:
- Niu Nan, MD
- Phone Number: 024-96615-31813
- Email: 2951878628@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cohort 1 Control Group: women without breast cancer or other malignancies. Case Group: patients with histologically confirmed carcinoma in situ or invasive breast cancer; no prior treatment; no distant metastasis; and not associated with other malignant tumor diseases.
- Cohort 2 Pathologically diagnosed as breast cancer; Treatment niave patients; To receive standard neoadjuvant therapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) .
- Cohort 3 Patients who have been discharged after breast cancer treatment.
Exclusion Criteria:
- Histologically undiagnosed breast cancer. Breast cancer with distant metastases. Combined with other malignant tumors. Participants must not have participated in other clinical trials within the past month, unless those trials are observational or non-interventional in nature.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cohort 1
women without breast cancer or other malignancies；breast cancer patients.
|
There is no intervention in this study.
We will obtain blood from the recruited patients and assess the metabolites therein.
This is an observational work.
|
|
cohort 2
patients diagnosed with breast cancer who received standard neoadjuvant therapy.
|
There is no intervention in this study.
We will obtain blood from the recruited patients and assess the metabolites therein.
This is an observational work.
|
|
Cohort 3
patients who have been discharged after breast cancer treatment.
|
There is no intervention in this study.
We will obtain blood from the recruited patients and assess the metabolites therein.
This is an observational work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohort 1 : Different Plasma Metabolites
Time Frame: 2 years
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To measure the plasma metabolites of non-tumor individuals and breast cancer patients, and to analyze the differential metabolites between the two populations.
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2 years
|
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Cohort 2: Different Plasma Metabolites
Time Frame: 2 years
|
pCR refers to the complete pathological remission of tumor lesions following neoadjuvant chemotherapy.
To measure the plasma metabolites of breast cancer patients both before and after neoadjuvant chemotherapy, and to analyze the differential metabolites between patients who achieve pCR and those who do not.
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2 years
|
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Cohort 3: Different Plasma Metabolites
Time Frame: 7 years
|
The metabolites in the blood of discharged breast cancer patients were measured regularly, and the differences in metabolites between patients with disease recurrence or metastasis and those without recurrence or metastasis within a 5-year period were analyzed.
|
7 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUKDEN-METAB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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