CancerW001NCT03400514
Clinical Concordance Study Between Watson for Oncology and Clinician Practice
An observational study of Cancer and Artificial Intelligence, run by Qingdao University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Artificial Intelligence
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2017to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cancer patients from outpatient and inpatient in our hospital
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Xiaoxhun Zhang, 086053282913271, zxc9670@126.com
Xiaochun Zhang
About this study
Official title: A Retrospective, Self - Controlled, Single - Center Clinical Concordance Study Between Watson for Oncology and Clinician Practice
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.
Read the 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.
- Conditions
- Cancer, Artificial Intelligence
- Keywords
- Artificial intelligence, concordance
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance
the concordance of therapeutic regimen between WFO and physicians in the Affiliated Hospital of Qingdao University
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start12 Apr 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochun Zhang, Qingdao University
- Investigators
- Xiaochun Zhang, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400514
- Sponsor's protocol ID
- XCZhang001
- Acronym
- W001
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30181315
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Self - Controlled, Single - Center Clinical Concordance Study Between Watson for Oncology and Clinician Practice
- ClinicalTrials.gov ID
- NCT03400514
- Acronym / sponsor ID
- W001 / XCZhang001
- Conditions
- Cancer, Artificial Intelligence
- Keywords
- Artificial intelligence, concordance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients from outpatient and inpatient in our hospital
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concordance
Time frame: Day 0
the concordance of therapeutic regimen between WFO and physicians in the Affiliated Hospital of Qingdao University
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 30181315Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaochun Zhang principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Artificial Intelligence, run by Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Zhou (+86053282913207, zhounabb0912@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.