NCT04145947

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.

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
6 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

10 months

First QC Date

October 29, 2019

Last Update Submit

November 14, 2019

Conditions

Triple Negative 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)

triple negative breast cancer

triple negative breast cancer patients with age ≤ 60 years old

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

triple negative breast cancer patients with age ≤ 60 years old

You may qualify if:

  • 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

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

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xi Shen

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Shen

CONTACT

+86-18611768360shenxisx@sohu.com

Study Design

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

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

April 25, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2025

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

CN(1)