Breast Cancer Chemotherapy Risk Prediction Mathematical Model (BCCRPMM)

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Xi'an Jiaotong University

Status

Unknown

Conditions

Breast Neoplasms

Study type

Observational

Funder types

Other

Identifiers

NCT02547545
XJTU1AF2012LSK-021

Details and patient eligibility

About

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.

Full 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.

Enrollment

795 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

795 participants in 1 patient group

All
Description:
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.

Trial contacts and locations

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Central trial contact

Yi Liu, MD,PHD; Ye Sun, MD,PHD

Data sourced from clinicaltrials.gov

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