NCT05305092 Assessment of Brain Cognitive Impairment in Breast Cancer
| NCT ID | NCT05305092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tang-Du Hospital |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-05-31 |
| Primary Completion | 2027-05-30 |
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 90 participants in total. It began in 2022-05-31 with a primary completion date of 2027-05-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * Patients with primary stage I-II breast cancer. * 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: * Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function. * 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.
Contact & Investigator
Menghui Yuan, phd
PRINCIPAL INVESTIGATOR
Tang-Du Hospital
Frequently Asked Questions
Who can join the NCT05305092 clinical trial?
This trial is open to female participants only, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05305092 currently recruiting?
Yes, NCT05305092 is actively recruiting participants. Contact the research team at yuanmenghui@163.com for enrollment information.
Where is the NCT05305092 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT05305092 clinical trial?
NCT05305092 is sponsored by Tang-Du Hospital. The principal investigator is Menghui Yuan, phd at Tang-Du Hospital. The trial plans to enroll 90 participants.
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