Metabolomics Explores Biomarkers for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302415
• Other study ID #: OMICS Mark
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong YU, PhD
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis.

PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.

Description:

Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.

Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2023
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 yrs.

• Any menopausal status.

• Any hormone receptor status.

• Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.

• Patients must have measurable disease, per RECIST criteria v1.1.21.

• Estimated life expectancy of = 12 weeks.

• Ability to swallow oral medications.

• Participants must have adequate organ function as defined by:

1. ANC =1.5 x 109/L, platelet count =100 x 109/L, haemoglobin = 10 g/dL.

2. creatinine < 1.5 x UNL (upper normal limit).

3. Total bilirubin < 1.5x UNL.

4. ALT & AST < 2.5xUNL; alkaline phosphatase < 2.5xUNL.

5. Creatine phosphokinase (CPK) = 2.5 x UNL.

• Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.

Exclusion Criteria:

• Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).

• History of other malignancies.

• No measureable lesion is present, as defined by RECIST 1.1.

• Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.

• Concurrent interventional studies.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• There is no other intervention, only clinical treatment.
There is no other intervention, only clinical treatment.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).	To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.	up to six months
Secondary	progression of disease	To observe the duration from the stable condition to progression of disease. Patients were followed up every six months in first five years, then followed up once a year.	Up to 10 years
Secondary	overall survival	To observe the duration from the stable condition to death. Patients were followed up every six months in first five years, then followed up once a year.	Up to 10 years