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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

From the registry’s dates

  • Started Jun 2017; still recruiting 9 years 5 months later.
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

In context

Thyroid Diseases

365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.

This study's planned enrollment of 400 is above the median of 198 across 158 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University is the lead sponsor of 18 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female patients with or cytologically proven primary breast cancer;
  2. Age >18 years;
  3. Performance Status: 0-2;
  4. : 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 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 .
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
    Bengbu, Anhui 233004, China
    Recruiting
    • Yan Yang, M.D., Ph.D. · Contactqiannianhupo@163.com · +86-552-3086178
    • Qiong Wu, M.D., Ph.D. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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