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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above