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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06698679
• Lead Sponsor: Shengjing Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-13
• Study Start: 2024-11-15
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2031-06-30
• Study Completion: 2031-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort 1 : Different Plasma Metabolites	2 years	To measure the plasma metabolites of non-tumor individuals and breast cancer patients, and to analyze the differential metabolites between the two populations.
Cohort 2: Different Plasma Metabolites	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.
Cohort 3: Different Plasma Metabolites	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.

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China