Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients

Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood

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

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer

Detailed Description

200 patients with triple negative 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: Xi Shen; Phone Number: +86-18611768360; Email: shenxisx@sohu.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xi Shen; Phone Number: +86-18611768360; Email: shenxisx@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

triple negative breast cancer patients with age ≤ 60 years old

Description

Inclusion Criteria:

• Female
• Postoperative pathology confirmed invasive breast cancer after surgery for breast lump
• Breast cancer-related chemotherapy and radiotherapy completed
• triple negative breast cancer patients
• 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
triple negative breast cancer; triple negative breast cancer patients with age ≤ 60 years old

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: Xi Shen, Peking Union Medical College Hospital

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: October 29, 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; Triple Negative Breast Neoplasms
• Other Study ID Numbers: PUMCH-BC502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No