Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer

Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood

The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yali Xu; Phone Number: +86-13717761030; Email: 49950757@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yali Xu; Phone Number: +86-13717761030; Email: 49950757@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with high risk of recurrence and metastasis of breast cancer

Description

Inclusion Criteria:

• Female
• Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors
• Breast cancer-related chemotherapy and radiotherapy completed
• axillary lymph node metastasis ≥ 4
• age ≤ 60 years old

Exclusion Criteria:

• Male
• Aged above 60
• Breast Carcinoma in situ
• Women in pregnancy or breastfeeding
• Suffering from other malignant tumors
• Non-compliant patient

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lymph node metastasis; Axillary lymph node metastasis ≥ 4 Lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune inflammation-related protein complexes	The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography.	2 years
blood markers	The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay.	2 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yali Xu

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PUMCH-BC500

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