NCT04145973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

October 29, 2019

Last Update Submit

November 14, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • immune inflammation-related protein complexes

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

    2 years

  • blood markers

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

    2 years

Study Arms (1)

recurrence and metastasis

breast cancer patients with recurrence and metastasis after surgery

Eligibility Criteria

Age36 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe participant eligibility is based on the physiological sex.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with recurrence and metastasis of breast cancer

You may qualify if:

  • 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

You may not qualify if:

  • Male
  • Aged above 60
  • Breast Carcinoma in situ
  • Women in pregnancy or breastfeeding
  • Suffering from other malignant tumors
  • Non-compliant patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1 mL of blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chang Chen

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Chen

CONTACT

+86-18800158277277630399@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2025

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

CN(1)