Clinical trial NCT06698679: The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer
Official title: The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: metabolites
breast cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants included individuals without tumors, patients diagnosed with breast cancer , and patients who have been discharged after breast cancer treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 1 : Different Plasma Metabolites
timeFrame: 2 years
measure: Cohort 2: Different Plasma Metabolites
timeFrame: 2 years
measure: Cohort 3: Different Plasma Metabolites
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References: