Breast Cancer Chemotherapy Risk Prediction Mathematical Model

NCT ID: NCT02547545

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

795 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Liu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

+86 18991232576

Locations

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First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Liu, MD,PHD

Role: CONTACT

+86 18991232576

Ye Sun, MD,PHD

Role: CONTACT

+86 18991232575

Facility Contacts

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Yi Liu, MD.;PhD.

Role: primary

86-18991232576

Other Identifiers

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XJTU1AF2012LSK-021

Identifier Type: -

Identifier Source: org_study_id

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