The Establishment of a Survival Prediction Model for ER P... | NCT04683757

Studies
The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer

NCT04683757

Sponsor

Ying Wang

Status

Unknown status

Last Update Posted

Dec 24, 2020Actual

Enrollment

288Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Establishment of a Survival Prediction Model

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

Dec 2020

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

Jan 1, 2020Actual

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 19, 2020

First Submission Date that Met QC Criteria

Dec 19, 2020

First Posted Date

Dec 24, 2020Actual

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

Dec 19, 2020

Last Update Posted Date

Dec 24, 2020Actual

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

This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

288Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Establishment of a Survival Prediction Model	Other	a nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival，OS	The time from the beginning of treatment to the death of the patient	5 years
Tumor specific survival time, CSS	The follow-up started from the first day of confirmed recurrence and metastasis. The end point of follow-up was the death caused by tumor related causes.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival，PFS	The time from the beginning of treatment to the progression or death of the patient.	2 years
5-year survival rate	the survival rate in 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
Patients who are willing to receive follow-up treatment in the research center.

Exclusion Criteria:

ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
Combined with other malignant tumors or had other malignant tumors in recent 5 years
Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
Patients with life expectancy less than 3 months

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

breast cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Dr. Wang, doctor	Contact	86-20-34070499		wangy556@mail.sysu.edu.cn
Jianli Zhao	Contact	86-20-34070870		zhaojli5@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat Sen Memorial Hospital，Sun Yat sen University	Completed	Guangzhou	Guangdong	510000	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

ID	Term
D001943	Breast Neoplasms

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

Description

The target of this study is to detect the gene mutation of tumor tissue or peripheral blood circulation tumor DNA of tumor patients. 10ml of tissue or fresh peripheral blood should be collected as the test sample and stored at room temperature. On the same day, it was sent to the "cell and molecular diagnosis center" of our hospital for DNA isolation and extraction, secondary sequencing, and detection of related biomarkers, such as erbB2 / TP53 / PIK3CA / ErbB4 / CCND1.