Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery

Breast Cancer Clinical Trial

Official title:

Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery Via Analysis of Immunoinflammation-related Protein Complexes in Blood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145973
• Other study ID #: PUMCH-BC501
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: March 2025

Study information

• Verified date: November 2019
• Source: Peking Union Medical College Hospital
• Contact: Chang Chen
• Phone: +86-18800158277
• Email: 277630399[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

200 patients with breast cancer and recurrence or metastasis after surgery 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

• invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump

• Breast cancer-related chemotherapy and radiotherapy completed

• breast cancer patients with recurrence and metastasis after surgery

Exclusion Criteria:

• Male

• Aged above 60

• Breast Carcinoma in situ

• Women in pregnancy or breastfeeding

• Suffering from other malignant tumors

• Non-compliant patient

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

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