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RecruitingNCT03177902Updated Sep 4, 2026

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

An observational study in Breast Cancer Female and Thyroid Gland, sponsored by The First Affiliated Hospital of Bengbu Medical University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by The First Affiliated Hospital of Bengbu Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 85 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer Female
  • Thyroid Gland

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03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Newly diagnosed female breast cancer

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational group

    Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy

    Drug: Chemotherapy

  • Control group

    Healthy Volunteers

Interventions

  • DrugChemotherapy

    Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.

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What researchers measure

Primary outcomes

  1. Number of participants newly diagnosed with breast cancer

    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.

    Time frame: 1 week around the indicated detection point

06

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
    Bengbu, Anhui 233004, China
    • Yan Yang, M.D., Ph.D. · Contact · qiannianhupo@163.com · +86-552-3086178
    • Qiong Wu, M.D., Ph.D. · Principal investigator
    Recruiting
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Registry details

Key details

Study ID
NCT03177902
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Responsible party
Yan Yang, MD, Ph.D (Principal Investigator, The First Affiliated Hospital of Bengbu Medical University) — Principal investigator
First posted
Jun 6, 2017
Start date
Jun 4, 2017
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Yan Yang, M.D.,Ph.D.
Contact
qiannianhupo@163.com
+86-552-3086178
Qiong Wu, M.D.,Ph.D.
principal investigator · The First Affiliated Hospital of Bengbu Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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