SCOOT: Sample Collection for DART

Lung Cancer Clinical Trial

— SCOOT  

Official title:

Sample Collection for The Integration and Analysis of Data Using Artificial Intelligence to Improve Patient Outcomes With Thoracic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368298
• Other study ID #: OCTO-106
• Status: Recruiting
• Start date: August 11, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: University of Oxford
• Contact: Lakisha Marshall
• Phone: 01865 617420
• Email: octo-scoot[@]oncology.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will use a blood sample collected from participants to:

• Develop new ways of finding and diagnosing lung health problems, such as lung cancer.

• Develop tools which make it easier to screen people with possible lung health problems, diagnose problems earlier and with fewer tests, and start the best treatment faster.

• Help improve the early diagnosis of lung cancer, as finding lung cancer early means that it can be treated more easily and successfully.

Description:

The results from this study will be linked with the data from the DART study (also collecting data through the Lung Health Check programme) to develop new ways of using computer technology (artificial intelligence) to improve lung health care. The studies use computer programs (called 'algorithms') which can be trained to analyse medical samples. Once developed, these algorithms can be used to support doctors by increasing their speed and accuracy of diagnosing issues.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Patient suitability will be assessed against the below criteria by the clinical teams managing the patients.

Inclusion Criteria:

1. Patients with a pulmonary nodule or nodule(s) detected on a CT scan performed as part of Lung Cancer Screening from the Lung Health Check centres, that require further investigation with a PET-CT scan, and / or biopsy, and / or resection

2. Willing and able to give informed consent

Exclusion Criteria:

• None -

Related Conditions & MeSH terms

• Lung Cancer

Locations

Country	Name	City	State
United Kingdom	Lung Health Check Centre: Royal Sussex	Brighton
United Kingdom	Lung Health Check Centre: North Bristol	Bristol
United Kingdom	Lung Health Check Centre: Gateshead	Gateshead
United Kingdom	Lung Health Check Centre: Corby & Kettering	Kettering
United Kingdom	Lung Health Check Centre: Cheshire & Merseyside	Liverpool
United Kingdom	Lung Health Check Centre: RM Partners	London
United Kingdom	Lung Health Check Centre: Newcastle & Gateshead	Newcastle
United Kingdom	Lung Health Check Centre: Plymouth	Plymouth
United Kingdom	Lung Health Check Centre: Stoke	Stoke
United Kingdom	Lung Health Check Centre: South Tyneside and Sunderland	Sunderland

Sponsors (7)

Lead Sponsor	Collaborator
University of Oxford	Cancer Research UK, GE Healthcare, Innovate UK, National Institute for Health Research, United Kingdom, Optellum, Roche Pharma AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT algorithm compared to not using them		by July 2024
Secondary	To develop an algorithm that gives a greater than chance improved ability to diagnose lung cancer using the blood biomarkers with or without the AI CT and blood markers algorithm compared to not using them		by July 2024

External Links

•   Cancer Research UK webpage containing information about the Lung Health Check programme
•   OCTO webpage containing information about the SCOOT trial