Evaluation of Prognostic Monitoring for Young Breast Cancer Patients

November 14, 2019 updated by: Na Shi, Peking Union Medical College Hospital

Evaluation of Prognostic Monitoring for Young Breast Cancer Patients 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 with completed standard treatment for young ladies will be studied.

Study Overview

Status

Recruiting

Conditions

Detailed Description

200 patients younger than 35 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients with ages equal 35 or below.

Description

Inclusion Criteria:

  • Female
  • invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump
  • Breast cancer-related chemotherapy and radiotherapy completed
  • Young ladies with ages equal 35 or below

Exclusion Criteria:

  • Male
  • Aged above 35
  • Breast Carcinoma in situ
  • Women in pregnancy or breastfeeding
  • Suffering from other malignant tumors
  • Non-compliant patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
young ladies
Young ladies≤ 35 years old.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Shi Na, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • PUMCH-BC503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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