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NCT04145947 Clinical Trial

Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04145947
Other study ID # PUMCH-BC502
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 25, 2019
Est. completion date March 2025

Study information
Verified date November 2019
Source Peking Union Medical College Hospital
Contact Xi Shen
Phone +86-18611768360
Email shenxisx@sohu.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date March 2025
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender Female
Age group 36 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

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