An observational study in Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by RenJi Hospital · Observational
The study evaluates the protective effect of low-dose aspirin use as adjuvant therapy on locally advanced renal cell carcinoma in users and non-users of aspirin in Renji Hospital, Shanghai, China.
Renal cell carcinoma (RCC) accounts for 2%\~3% of all malignant tumors worldwide. In China, the incidence of renal cancer is increasing year by year. It is reported about one-third of patients were at late stage when diagnosed while about one-third of patients who received surgical treatment would eventually lead to recurrence or metastasis. The 5-years survival is only about 50% in patients with locally advanced RCC, which lacks of effective adjuvant treatments, although the S-TRAC study showed improved Disease-free Survival (DFS) in high-risk renal cell carcinoma after nephrectomy.
Aspirin, also called acetylsalicylic acid, belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Its inhibitory effect on platelet aggregation makes it widely used in cardiovascular and cerebrovascular diseases. In addition, a number of epidemiology, basic and clinical researches confirmed that aspirin may be the most promising chemopreventive agent to date, especially against CRC. Prospective studies have also shown that aspirin can improve survival of patients with breast cancer,colorectal cancer, gastro-esophageal cancer and prostate cancer.
In the investigator's clinical practice, we'd like to investigate the preventive effects of low-dose aspirin use as an adjuvant therapy after radical nephrectomy on disease recurrence/metastasis and survival in patients with locally advanced renal cell carcinoma in Renji Hospital affiliated to Shanghai Jiao Tong University school of medicine. The study is observational and prospective, patients with locally advanced RCC will decide whether or not to take low-dose Aspirin(100mg/d) after radical nephrectomy as adjuvant therapy for 1 year. The primary end point was the duration of disease-free survival, and the secondary end points included overall survival and safety.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 260 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
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patients with locally advanced renal cell carcinoma undergoing radical nephrectomy
Exclusion Criteria:
After surgery, patients would use low-dose aspirin (100mg) longer than 1 year
Drug: Low dose of aspirin
After surgery, patients would not use low-dose aspirin or use asprin shorter than 1 year
Low dose of aspirin, 100 mg daily for longer than one year
Disease-free Survival
Disease-free Survival
Time frame: 36 mouths
Overall survival
Overall survival
Time frame: 36 months
Cancer specific survival
Cancer specific survival
Time frame: 36 months
adverse event rate
Rate of patients with each of the adverse event per grade
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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RenJi Hospital