A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

NCT ID: NCT04970264

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2025-03-31

Brief Summary

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.

We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

Detailed Description

The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.

All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.

In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed as breast cancer.

2. The age of diagnosis was 18-35 years old.

3. ECOG score was 0-2, and the expected survival time was more than 3 months.

4. No serious complications; no liver, kidney, hematopoiesis dysfunction.

5. Informed consent, and patients willing to long-term follow-up. -

Exclusion Criteria

1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.

2. Having a clear history of neurological or mental disorders (including epilepsy or dementia).

3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.

4. Pregnant or lactating female patients.

5. HIV infected patients.

6. Patients with other tumors.

7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TianJin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong MD Liu, professor

Role: CONTACT

lh713@163.com

18622221169

Facility Contacts

Hong MD Liu, professor

Role: primary

lh713@163.com

18622221169

Other Identifiers

YWBC-001

Identifier Type: -

Identifier Source: org_study_id