Treatment of Older Adults with Cancer - Addressing Gaps in Evidence.
Monica M Bertagnolli, Harpreet Singh
https://pubmed.ncbi.nlm.nih.gov/34506087Actively Recruiting
Led by Qilu Hospital of Shandong University · Updated on 2025-03-24
35
Participants Needed
1
Research Sites
417 weeks
Total Duration
Researchers are investigating elderly female patients aged 65 years and older with Luminal A type breast cancer that has spread to lymph nodes after surgery. This observational study aims to assess whether a 21-gene assay can predict survival outcomes and the benefits of chemotherapy in these patients. The study focuses on clinical and pathological data including imaging, treatment plans, and medication strategies to better understand disease progression and treatment impact. The study collects paraffin tissue samples from both the primary breast cancer and metastatic lymph nodes for a 21-gene assay, which calculates a recurrence risk index. Patients will be followed every 12 months after surgery to monitor for disease recurrence. After recurrence, survival is followed every three months until death. This approach allows researchers to observe real-world treatment effects and outcomes without administering experimental treatments. Participants will have their clinical information and treatment details recorded, including whether chemotherapy, radiotherapy, endocrine therapy, or targeted therapy were used after surgery. Follow-up includes regular assessments and survival tracking until the patient reaches age 80 or passes away. Data collected will help evaluate the predictive value of the 21-gene assay and guide treatment decisions for elderly breast cancer patients with lymph node involvement.
CONDITIONS
21-gene in Elder Breast Cancer Patients With Lymph Node Metastasis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
21-gene assay will be performed on the primary breast cancer site and metastatic lymph nodes to assess prognosis.
1 visit (in-person)
Duration - From enrollment to 80 years old or mortality
Participants are observed for health outcomes up to average life expectancy or until mortality.
Periodic visits as needed
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
J
Jiang Zhu, M.D. & Ph.D.
X
Xiao Wang, M.D. & Ph.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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