Clinical trial NCT03400514: Clinical Concordance Study Between Watson for Oncology and Clinician Practice
Official title: A Retrospective, Self - Controlled, Single - Center Clinical Concordance Study Between Watson for Oncology and Clinician Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Artificial Intelligence
Keywords: Artificial intelligence
concordance
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients from outpatient and inpatient in our hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* not have confirmed diagnoses of invasive cancer
* under 18 years of age
* pregnant
* with multiple concurrent primary cancers or a local recurrence or a new primary at the same site of a previously treated cancer

Primary outcomes:
measure: concordance
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Xiaochun Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou N, Zhang CT, Lv HY, Hao CX, Li TJ, Zhu JJ, Zhu H, Jiang M, Liu KW, Hou HL, Liu D, Li AQ, Zhang GQ, Tian ZB, Zhang XC. Concordance Study Between IBM Watson for Oncology and Clinical Practice for Patients with Cancer in China. Oncologist. 2019 Jun;24(6):812-819. doi: 10.1634/theoncologist.2018-0255. Epub 2018 Sep 4.