Evaluation of Prognostic Monitoring for Women Who Have Co... | NCT04145960

Studies
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer

NCT04145960

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Nov 18, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2019Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2019

Last Update Posted Date

Nov 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yali XU, Principal Investigator, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.

Detailed Description

200 patients 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lymph node metastasis		Axillary lymph node metastasis ≥ 4 Lymph nodes

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors
Breast cancer-related chemotherapy and radiotherapy completed
axillary lymph node metastasis ≥ 4
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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

The participant eligibility is based on the physiological sex.

Minimum Age

Not provided

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Patients with high risk of recurrence and metastasis of breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yali Xu	Contact	+86-13717761030		49950757@qq.com

Overall Officials

Name	Affiliation	Role
Yali Xu		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided