Assessment of Brain Cognitive Impairment in Breast Cancer
NCT ID: NCT05305092
Last Updated: 2022-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2022-05-31
2027-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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chemotherapy
Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Endocrine therapy
Premenopausal breast cancer patients receiving endocrine therapy alone after surgery
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Healthy control
Healthy non-cancer controls
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Interventions
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PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Eligibility Criteria
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Inclusion Criteria
* Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
* No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
* Eastern Cooperative Oncology Group score of 0-1 points.
* Can understand and complete various scales.
* Right handedness.
* Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
* Sign the informed consent and voluntarily participate in this clinical observation.
Exclusion Criteria
* Current or former epilepsy, dementia, or learning disabilities.
* Past psychiatric history.
* Past history of malignancy.
* MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
FEMALE
Yes
Sponsors
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Xi'an Jiaotong University
OTHER
Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Menghui Yuan, phd
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Locations
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Tangdu Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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82071993
Identifier Type: -
Identifier Source: org_study_id
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