A Retrospective, Self - Controlled, Single - Center Clinical Concordance Study Between Watson for Oncology and Clinician Practice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- concordance
研究概览
简要总结
At present, Watson for Oncology has been applied in 14 countries worldwide, including China, the United States, Holland, Thailand, India, Korea, Poland, Slovakia and Bangladesh. In a double-blind study involving 362 patients in India, treatment recommendations from Watson for Oncology (WFO) performed a high degree of consistency with their multidisciplinary tumor board. The investigators would recruit cancer patients diagnosed as lung cancer, breast cancer, gastric cancer, colon cancer， rectal cancer，cervical cancer or ovarian cancer according to the criteria of Watson for Oncology ，using the updated version of Watson for Oncology to explore the concordance of therapeutic regimen between WFO and physicians in the Affiliated Hospital of Qingdao University.
详细描述
This study was approved by the Affiliated Hospital of Qingdao University ethics committee.The investigators would randomly selected cancer patients, including lung cancer, breast cancer, gastric cancer, colon cancer，rectal cancer，cervical cancer and ovarian cancer patients, from the Affiliated Hospital of Qingdao University database according to the criteria of Watson for Oncology(supplementary materials). Case data would be extracted and input into the Watson system. WFO provided therapeutic recommendations in three categories: recommended, for consideration, and not recommended. Data would be analyzed retrospectively to compare the WFO's recommendations and actual therapeutic regimen in the hospital. Some actual regimen applications that were not available in WFO will be defined as "physician's choice". Overall, physician's recommendations would be defined as concordant with WFO if they corresponded to the recommended or consideration categories and as non-concordant if they corresponded to the not recommended or not available categories.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a histology of lung cancer,breast cancer,gastric cancer, colon cancer， rectal cancer，cervical cancer and ovarian cancer
- •had no prior systemic therapy and need neoadjuvant/adjuvant or metastatic therapy
- •had prior neoadjuvant therapy, adjuvant therapy and/or surgery and are now metastatic
- •have had prior surgery and now need adjuvant therapy
- •seeking an additional therapy whose cancer has progressed beyond its initial metastatic therapy (second line)
排除标准
- •not have confirmed diagnoses of invasive cancer
- •under 18 years of age
- •with multiple concurrent primary cancers or a local recurrence or a new primary at the same site of a previously treated cancer
结局指标
主要结局
concordance
时间窗: Day 0
the concordance of therapeutic regimen between WFO and physicians in the Affiliated Hospital of Qingdao University
次要结局
未报告次要终点
研究者
Xiaochun Zhang
Professor
Qingdao University