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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04145973
Collaborator
(none)
200
Enrollment
1
Location
71
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 and recurrence or metastasis of breast cancer with completed standard treatment will be studied.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Mar 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    recurrence and metastasis

    breast cancer patients with recurrence and metastasis after surgery

    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

    • 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

    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: Chang Chen, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Chen, Principal Investigator, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04145973
    Other Study ID Numbers:
    • PUMCH-BC501
    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
    Recurrence

    Study Results

    No Results Posted as of Nov 18, 2019