Breast Cancer Chemotherapy Risk Prediction Mathematical Model (BCCRPMM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 795

Contacts and Locations

Study Locations

• China
  • Xi'an, China, 710061
    • Recruiting
    • First Affiliated Hospital of Xian Jiaotong University
    • Contact: Yi Liu, MD.;PhD.; Phone Number: 86-18991232576

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

breast cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All; The side effects after chemotherapy were observed for all patients. Potential risk factors would be explored for the side effects such as chemotherapy realted vomit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Shaanxi Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Yi Liu, MD,PHD, +86 18991232576

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: XJTU1AF2012LSK-021