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Construction and verification of Chinese medicine syndrome differentiation diagnostic criteria for early breast cancer

Registration number：

ITMCTR2200006139

Date of Last Refreshed on：

2022-06-15

Date of Registration：

2022-06-15

Registration Status：

Prospective registration

Public title：

Construction and verification of Chinese medicine syndrome differentiation diagnostic criteria for early breast cancer

English Acronym：

Scientific title：

Construction and verification of Chinese medicine syndrome differentiation diagnostic criteria for early breast cancer

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200061022 ; ChiMCTR2200006139

Applicant：

Qianqian Guo

Study leader：

Qianjun Chen

Applicant telephone：

15915740853

Study leader's telephone：

18688883505

Applicant Fax：

Study leader's fax：

Applicant E-mail：

guoqianqian@gzucm.edu.cn

Study leader's E-mail：

cqj55@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangdong Provincial Hospital of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

ZE2022-142-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Xiaoyan Li

Contact Address of the ethic committee：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Address：

111 Dade Road, Yuexiu District

Source(s) of funding：

None

Target disease：

Breast cancer

Target disease code：

Study type：

Observational study

Study design：

Cross-sectional

Study phase：

Others

Objectives of Study：

The aim of the study is to validate the clinical diagnostic efficacy of the diagnostic criteria.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1)Patients whose pathology meets the diagnostic criteria of early breast cancer (stage I-III, excluding distant metastasis); (2)Female patients over 18 years old (including 18 years old); (3)Patients with a score of 0-2 in ECOG (Eastern Cooperative Oncology Group); (4)Patients who voluntarily participated in the study and signed informed consent.

Exclusion criteria：

(1)Serious accompanying diseases such as cardio-cerebrovascular or psychological disease; (2)Receiving the neoadjuvant, or receiving the chemotherapy, radiotherapy, or endocrine treatment simultaneously; (3)Complications of breast cancer treatment, such as postoperative wound infection, severe lymphoedema, neutropenic fever or radiation pneumonia; (4) Pregnant or breastfeeding participants.

Study execute time：

From 2022-06-01

To      2023-10-31

Recruiting time：

From 2022-06-01

To      2023-10-31

Interventions：

630

Group：

Case collection

Sample size：

Intervention：

None

Intervention code：

Total sample size ： 630

Countries of recruitment
and research settings：

Country：

China

Province：

Zhejiang

City：

Institution/hospital：

Zhejiang Provincial Hospital of TCM

Level of the institution：

Tertiary A

Country：

China

Province：

Shandong

City：

Institution/hospital：

The affiliated Hospital of Shandong University of TCM

Level of the institution：

Tertiary A

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Jiangsu Province Hospital of Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Sichuan

City：

Institution/hospital：

Chongqing Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Hainan

City：

Institution/hospital：

Sanya Maternal and Child Care Service Centre

Level of the institution：

Tertiary A

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Hunan

City：

Institution/hospital：

The First Hospital of Hunan University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Signs and symptoms, Chinese medicine syndromes and Chinese herbal formulas.

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

No need to randomize.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Please contact the author via email if you need raw data (Email: guoqianqian@gzucm.edu.cn)

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management are operated with Epidata software.

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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