Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06698679

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Niu Nan, MD

CONTACT

[email protected]

024-96615-31813

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

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.

Primary outcomes

  1. 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. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Cai Gang, Ph. D

CONTACT

[email protected]

15140067366

Liu Hua, Ph. D

CONTACT

[email protected]

15140067366

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.