Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Location status: Recruiting
NCT Number: NCT06891651
This study is a single-center, bidirectional cohort study. It aims to include 35 elderly (≥65 years old) Luminal A type breast cancer patients with axillary lymph node metastasis after surgery as the research subjects. After signing the informed consent, the patients who meet the inclusion criteria will have their various clinical and pathological data collected (preoperative imaging examinations, clinical and pathological information of the patients, basic disease conditions and medication strategies, surgical records, postoperative planned treatment plans and actual treatment situations, etc.), and their real adjuvant treatment situations (whether chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc. were performed after surgery) will be followed up and recorded. At the same time, paraffin tissues of breast cancer and metastatic lymph nodes of the patients will be collected from the pathology department of our hospital for 21-gene assay, and the recurrence risk index of the primary lesion and metastatic lymph nodes will be obtained using the risk index calculation logic of Amoy Diagnostics Company. An assessment will be conducted every 12 months after surgery until disease recurrence. After disease recurrence, survival follow-up will be conducted every three months until the patient's death. The predictive value of 21-gene assay for patient survival and whether chemotherapy is beneficial will be evaluated based on the follow-up data of the patients.
Interested in participating?
Request Info65 year and older
Female
Observational
Jinan, Shandong, 250012, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to 80 years old(Average life expectancy)or mortality.
All analyses will be conducted using SPSS 22.0. Comparisons between groups will be reported with 95% confidence intervals and p-values. Continuous variables will be presented as mean ± SD or median (min, max) based on distribution normality. Categorical variables will be described using frequencies (%).
Disease-Free Survival (DFS) Unit of measure: Months from postoperative baseline Assessment: Time to first radiological recurrence (RECIST v1.1) or death Method: Kaplan-Meier analysis with log-rank test
Time frame: From enrollment to 80 years old(Average life expectancy)or mortality.
Overall Survival (OS) Unit of measure: Months from enrollment Assessment: Time to all-cause mortality Method: Kaplan-Meier analysis
Contact information is provided by the study sponsor or research team.
Jiang Zhu, M.D. & Ph.D.
CONTACT
(+86)18560085173
Xiao Wang, M.D. & Ph.D.
CONTACT
(+86)18560081170
Qilu Hospital of Shandong University
Other
Clinical Cohort Study of 21-gene Assay in Predicting the Prognosis of Elder Luminal-A Breast Cancer Patients With Axillary Lymph Node Metastasis
Acronym: QiluElderHope
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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