- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177902
Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer
June 6, 2017 updated by: Qiong Wu, First Affiliated Hospital Bengbu Medical College
A Prospective Study to Assess Both Thyroid Abnormity Incidence In Chinese Women With Newly Diagnosed Breast Cancer and Thyroid Toxicity of Breast Cancer Patients Undergoing Chemotherapy
Breast cancer is one of the most common cancers in China.
Even though advances in the field of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality.
The cytotoxic therapies are generally associated with some immediate or otherwise delayed side effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological systems.
The effect of chemotherapy on endocrine system, however, is comparatively less envisaged.
Several epidemiological studies show a positive association between plasma thyroid hormones levels and breast cancer risk.
Thyroid dysfunction is emerging as a variably common endocrine toxicity of several anticancer drugs.
Due to the scarcity of data on the functioning of thyroid gland during chemotherapy in a large scale group, the present study was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or structure in these breast cancer patients undergoing at least four cycles of chemotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Yang, M.D.,Ph.D.
- Phone Number: +86-552-3086178
- Email: qiannianhupo@163.com
Study Locations
-
-
Anhui
-
Bengbu, Anhui, China, 233004
- Recruiting
- Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed female breast cancer
Description
Inclusion Criteria:
- Female patients with histologically or cytologically proven primary breast cancer;
- Age >18 years;
- ECOG Performance Status: 0-2;
- Life Expectancy: 3 months or more;
- No previous anti-cancer therapy;
- Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
- Adequate hematological, liver, and kidney functions.
Exclusion Criteria:
- Pregnancy or lactation;
- History of other malignancy or secondary breast cancer;
- History of thyroid disease;
- History of drug addiction or abuse;
- History of immunodeficiency disease;
- Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
- Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
- Inability to understand and agree to informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Healthy Volunteers
|
|
Observational group
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy
|
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants newly diagnosed with breast cancer
Time Frame: 1 week around the indicated detection point
|
Rate of thyroid function (measured by chemiluminescence methods) or structure (measured by ultrasonic imaging) abnormity at the time of diagnosis and during chemotherapeutic period will be reported.
|
1 week around the indicated detection point
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Qiong Wu, M.D.,Ph.D., First Affiliated Hospital of Bengbu Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 4, 2017
Primary Completion (ANTICIPATED)
April 1, 2019
Study Completion (ANTICIPATED)
June 1, 2019
Study Registration Dates
First Submitted
May 28, 2017
First Submitted That Met QC Criteria
June 3, 2017
First Posted (ACTUAL)
June 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 6, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BYEC20170502
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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