NCT03177902 Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer
| NCT ID | NCT03177902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Bengbu Medical University |
| Condition | Breast Cancer Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2017-06-04 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2017-06-04 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Qiong Wu, M.D.,Ph.D.
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Bengbu Medical University
Frequently Asked Questions
Who can join the NCT03177902 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03177902 currently recruiting?
Yes, NCT03177902 is actively recruiting participants. Contact the research team at qiannianhupo@163.com for enrollment information.
Where is the NCT03177902 trial being conducted?
This trial is being conducted at Bengbu, China.
Who is sponsoring the NCT03177902 clinical trial?
NCT03177902 is sponsored by The First Affiliated Hospital of Bengbu Medical University. The principal investigator is Qiong Wu, M.D.,Ph.D. at The First Affiliated Hospital of Bengbu Medical University. The trial plans to enroll 400 participants.
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