Breast NeoplasmsBCCRPMMNCT02547545
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
An observational study of Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 795 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
Yi Liu, MD.;PhD., 86-18991232576
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 795 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Yi Liu, MD,PHD, Principal investigator, +86 18991232576
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547545
- Sponsor's protocol ID
- XJTU1AF2012LSK-021
- Acronym
- BCCRPMM
- Status last verified
- Aug 2016
- First submitted
- 7 Sep 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macro-microscopic Syndrome Differentiation and Combination，Based on the "Chinese Medicine Clinical Phenotype" to Construct Breast Cancer Chemotherapy Risk Prediction Mathematical Model
- ClinicalTrials.gov ID
- NCT02547545
- Acronym / sponsor ID
- BCCRPMM / XJTU1AF2012LSK-021
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 795 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myelosuppression of chemotherapy
Time frame: 6 month
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.
1 secondary outcome
Chemotherapy related vomit (side effects of chemotherapy)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Liu, MD,PHD principal investigator
+86 18991232576
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu, MD,PHD (+86 18991232576, liuyi.jiaotong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myelosuppression of chemotherapy (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.