The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2031-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates plasma metabolites to clarify the relationship between these metabolites and breast cancer, aiming to identify valuable biomarkers. Furthermore, by incorporating clinical information-such as cancer stage, type, treatment outcomes, and prognosis-into prospective studies, the research seeks to further examine the correlation between plasma metabolites, treatment efficacy, and prognosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

NCT01198301

Breast Neoplasms Neoplasm Metastasis

COMPLETED

Study of Metabolites Markers in Adjuvant Breast Cancer

NCT03367208

Breast Neoplasms

COMPLETED

Studying Blood Samples in Women With Breast Cancer or a History of Breast Cancer

NCT00898703

Breast Cancer

COMPLETED

Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery

NCT04145973

Breast Cancer

UNKNOWN

Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer

NCT04145960

Breast Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cohort 1

women without breast cancer or other malignancies；breast cancer patients.

No intervention

Intervention Type OTHER

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.

No intervention

Intervention Type OTHER

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.

No intervention

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes