Breast Cancer Chemotherapy Risk Prediction Mathematical Model

Breast Neoplasms Clinical Trial

— BCCRPMM  

Official title:

Macro-microscopic Syndrome Differentiation and Combination，Based on the "Chinese Medicine Clinical Phenotype" to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02547545
• Other study ID #: XJTU1AF2012LSK-021
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2015
• Last updated: August 9, 2016
• Start date: September 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yi Liu, MD,PHD
• Phone: +86 18991232576
• Email: liuyi.jiaotong[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a cohort study. This study is to develop a predictive model of the side effects after chemotherapy, exploreing the potential risk factors of the side effects such as myelosuppression and chemotherapy realted vomit after the chemotherapy, so that it could help to alleviate patients' fear and anxiety about the side effects and the toxicity of chemotherapy. The potential risk factors were measured at baseline.

Description:

Firstly, the investigator will extact the "macro" information about physical conditon, which comes from syndrome-constitutional differentiation in the light of Traditonal Chinease Medicine (TCM) theory. Then combined with the "micro" information about pathological and biological markers, "TCM clinical phenotype" is extracted by Text Mining, and shows the full picture of the clinical features of breast cancer, which will include most of risk factors related to occurrence of adverse of chemotherapy fo breast cancer patients to establish two corresponding quatitative databases. Furthermore, predictive models will be built according to the predictors selected from an analysis on new methods of econometrics-Granger causality and cointegration analysis between "TCM clinical phenotype" and adverse effects of chemotherapy. The research results will be used to establish effective predictive models to lay the foundation for optimizing individualized treatment program of breast cancer by TCM and Western medicine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 795
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• THe female patients diagnosed with breast cancer by first histopathology;

• No tumor intervention therapy was conducted within one prior to the survey;

• KPS score=60;

• Patients without sever idiopathic disease;

• Patients who can independently respond to a questionnaire

• Those who signed informed consent

Exclusion Criteria:

• Patients with sever idiopathic disease of the gastrointestinal tract, heart and blood vessels, liver,kidney, hematopoietic system, endocrine system and so on;

• Patients with previous or nogoing application of drugs affecting bone marrow hemoatopoietic function;

• Patients who complicated with a serious infection or severe liquid sickness;

• Psychiatric patients;

• Those who can not independently respond to a questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Shaanxi Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myelosuppression of chemotherapy	Outcome is a bianry outcome, Yes or No variable. The primary outcome is wether the bone marrow suppression occurred or not for patients during the chemotherapy.	6 month	No
Secondary	Chemotherapy related vomit (side effects of chemotherapy)	Outcome is a bianry outcome, Yes or No variable. The secondary outcome is wether the chemotherapy realted vomit occurred or not for patients during the chemotherapy.	6 month	No