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

November 19, 2024 updated by: Caigang Liu, Shengjing Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: 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.
cohort 2
patients diagnosed with breast cancer who received standard neoadjuvant therapy.
Other: 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.
Cohort 3
patients who have been discharged after breast cancer treatment.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1 : Different Plasma Metabolites
Time Frame: 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.
2 years
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.
2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2024

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

October 31, 2031

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

October 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe