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Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04145947
Collaborator
(none)
200
Enrollment
1
Location
70.2
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood
    Actual Study Start Date :
    Apr 25, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Mar 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    triple negative breast cancer

    triple negative breast cancer patients with age ≤ 60 years old

    Outcome Measures

    Primary Outcome Measures

    1. immune inflammation-related protein complexes [2 years]

      The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography.

    2. blood markers [2 years]

      The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    36 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100005

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Xi Shen, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xi Shen, Attending doctor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04145947
    Other Study ID Numbers:
    • PUMCH-BC502
    First Posted:
    Oct 31, 2019
    Last Update Posted:
    Nov 18, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms

    Study Results

    No Results Posted as of Nov 18, 2019