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Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer

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ClinicalTrials.gov Identifier: NCT03177902
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Female Thyroid Gland Drug: Chemotherapy

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 4, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Observational group
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy
Drug: Chemotherapy
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
Control group
Healthy Volunteers


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed female breast cancer
Criteria

Inclusion Criteria:

  1. Female patients with histologically or cytologically proven primary breast cancer;
  2. Age >18 years;
  3. ECOG Performance Status: 0-2;
  4. Life Expectancy: 3 months or more;
  5. No previous anti-cancer therapy;
  6. Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
  7. Adequate hematological, liver, and kidney functions.

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. History of other malignancy or secondary breast cancer;
  3. History of thyroid disease;
  4. History of drug addiction or abuse;
  5. History of immunodeficiency disease;
  6. Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
  7. Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
  8. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
  9. Inability to understand and agree to informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177902


Contacts
Contact: Yan Yang, M.D.,Ph.D. +86-552-3086178 qiannianhupo@163.com

Locations
China, Anhui
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China, 233004
Contact: Yan Yang, M.D., Ph.D.    +86-552-3086178    qiannianhupo@163.com   
Principal Investigator: Qiong Wu, M.D., Ph.D.         
Sponsors and Collaborators
First Affiliated Hospital Bengbu Medical College
Investigators
Principal Investigator: Qiong Wu, M.D.,Ph.D. First Affiliated Hospital of Bengbu Medical College
More Information

Responsible Party: Qiong Wu, Principal Investigator, First Affiliated Hospital Bengbu Medical College
ClinicalTrials.gov Identifier: NCT03177902     History of Changes
Other Study ID Numbers: BYEC20170502
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Thyroid Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine System Diseases