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

NCT06698679 | Recruiting DMC

• 1 other identifier: MUKDEN-METAB
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

metabolites; breast cancer

Outcome Measures

Primary Outcomes (3)

• Cohort 1 : Different Plasma Metabolites

  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

  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

  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

Study Arms (3)

cohort 1

women without breast cancer or other malignancies；breast cancer patients.

Other: No intervention

cohort 2

patients diagnosed with breast cancer who received standard neoadjuvant therapy.

Other: No intervention

Cohort 3

patients who have been discharged after breast cancer treatment.

Other: No intervention

Interventions

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.

Cohort 3; cohort 1; cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liu Hua, Ph. D

CONTACT

15140067366; 20242027@cmu.edu.cn

Liu Cai Gang, Ph. D

CONTACT

15140067366; 20242027@cmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of oncology

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 21, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): October 31, 2031
• Last Updated: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)