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| Name | Class |
|---|---|
| Xi'an Jiaotong University | OTHER |
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To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.
Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy | Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery |
| |
| Endocrine therapy | Premenopausal breast cancer patients receiving endocrine therapy alone after surgery |
| |
| Healthy control | Healthy non-cancer controls |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample | Device | Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of gray matter volume of whole brain | Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image) | Baseline, 6,18,30 months later |
| Change of white matter integrity of whole brain. | Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging) | Baseline, 6,18,30 months later |
| Change of metabolism of glucose in the brain | Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography | Baseline, 6,18,30 months later |
| Change of functional connectivity of whole brain | Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence | Baseline, 6,18,30 months later |
| Change of verbal learning and memory | Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome. | Baseline, 6,18,30 months later |
| Change of information processing speed | Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome. | Baseline, 6,18,30 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the concentration of serum biomarkers. | The concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL | Baseline, 6,18,30 months later |
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Inclusion Criteria:
Exclusion Criteria:
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Premenopausal patients with stage I-II breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Menghui Yuan, phd | Contact | 0086-13519196610 | yuanmenghui@163.com | |
| Lijun Bai, phd | Contact | 0086-15129034948 | bailijun@xjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Menghui Yuan, phd | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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whole blood, gut microbiota
| Change of executive function |
Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome. |
| Baseline, 6,18,30 months later |
| Change of attention, verbal short term and working memory | Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome. | Baseline, 6,18,30 months later |
| Change of life quality. | Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome. | Baseline, 6,18,30 months later |
| Change of anxiety | Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome. | Baseline, 6,18,30 months later |
| Change of depression | Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome. | Baseline, 6,18,30 months later |
| Change of fatigue | Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome. | Baseline, 6,18,30 months later |
| Change of sleep | Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome. | Baseline, 6,18,30 months later |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |