Clinical Concordance Study Between Watson for Oncology and Clinician Practice

Cancer Clinical Trial

— W001  

Official title:

A Retrospective, Self - Controlled, Single - Center Clinical Concordance Study Between Watson for Oncology and Clinician Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400514
• Other study ID #: XCZhang001
• Status: Recruiting
• Phase: N/A
• First received: December 21, 2017
• Last updated: January 17, 2018
• Start date: April 12, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: January 2018
• Source: Qingdao University
• Contact: Na Zhou
• Phone: +86053282913207
• Email: zhounabb0912[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Cancer

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance	the concordance of therapeutic regimen between WFO and physicians in the Affiliated Hospital of Qingdao University	Day 0