Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
13035 participants
OBSERVATIONAL
2019-04-08
2030-08-31
Brief Summary
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Detailed Description
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SUMMIT plans to enrol 13,000 participants aged 55-77 years, from participating general practitioner (GP) practices in North Central and East London. The participants enrolled will be people who are at high-risk for lung cancer due to a significant smoking history based on validated risk scores.
Individuals with significant smoking histories will be offered a clinical Lung Health Check (LHC), which includes a brief respiratory consultation including questions about respiratory symptoms and medical history, smoking cessation advice and referral where required, and certain relevant clinical measurements (blood pressure, spirometry, height, and weight). Those persons who are eligible for participation based on specific validated risk scores may then be offered participation in the SUMMIT Study. Electronic informed consent will be obtained if they decide to take part. Consented participants will provide a blood sample, complete a confidential electronic questionnaire and have an LDCT scan at the same visit. Participants will be asked to return for two further annual visits, and some participants may return for additional scans if clinically indicated (nodule management).
If any LDCT result is suspicious for cancer, the participant will be referred to their local hospital (type 2 Site) via an urgent referral pathway to the relevant MDT. If a participant is diagnosed with lung cancer, that participant will no longer continue in the active/interventional part of the study but will be followed for clinical outcomes via the Type 2 site completion of eCRF and registry data. If the suspicious lesion is found to be benign, the participant can continue in the study.
There will be one randomisation round carried out during this study. All participants with a negative LDCT at the baseline visit who have not been diagnosed with lung cancer since that visit will return for an LHC at approximately 12 months. At the 12-month visit, this group will be randomised either to have an LDCT or no LDCT.
However, if an urgent referral was after the Y0 LDCT scan, the participant will not be included in the randomisation at Y1, and will receive LDCT at Y1 and Y2.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A (LDCT)
25,000 individuals who are at high-risk for lung cancer due to a significant smoking history.
Participants will receive at least 1 LDCT scan at baseline.
Low Dose CT scan
Low Dose chest CT scan conferring an equivalent radiation dose of less than 2 mSv to the average size patient. The study aims to keep most scans under 1 mSv (ultra-low dose), and all scans under 2 mSv.
Interventions
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Low Dose CT scan
Low Dose chest CT scan conferring an equivalent radiation dose of less than 2 mSv to the average size patient. The study aims to keep most scans under 1 mSv (ultra-low dose), and all scans under 2 mSv.
Eligibility Criteria
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Inclusion Criteria
1. USPSTF LDCT screening criteria: a history of at least 30 pack years of smoking and if a former smoker, have quit in the past 15 years; or
2. PLCOm2012 6-year lung cancer risk of ≥1.3%
2. Capable of providing informed consent and willing to comply with all parts of the protocol
Exclusion Criteria
55 Years
77 Years
ALL
Yes
Sponsors
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GRAIL, Inc.
INDUSTRY
University College London Hospitals
OTHER
University College, London
OTHER
Responsible Party
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Locations
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UCLH
London, , United Kingdom
Countries
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References
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Bhamani A, Creamer A, Verghese P, Prendecki R, Horst C, Tisi S, Hall H, Khaw CR, Mullin M, McCabe J, Gyertson K, Bowyer V, Arancon D, Eng J, Bojang F, Levermore C, Hacker AM, Arthur-Darkwa E, Farrelly L, Patel A, Lock S, Shaw A, Banka R, Bhowmik A, Ekeowa U, Mangera Z, Valerio C, Ricketts WM, Mohammed A, O'Shaughnessy T, Navani N, Quaife SL, Nair A, Devaraj A; SUMMIT consortium; Dickson JL, Hackshaw A, Janes SM. Low-dose CT for lung cancer screening in a high-risk population (SUMMIT): a prospective, longitudinal cohort study. Lancet Oncol. 2025 May;26(5):609-619. doi: 10.1016/S1470-2045(25)00082-8. Epub 2025 Mar 25.
Tisi S, Creamer AW, Dickson J, Horst C, Quaife S, Hall H, Verghese P, Gyertson K, Bowyer V, Levermore C, Hacker AM, Teague J, Farrelly L, Nair A, Devaraj A, Hackshaw A, Hurst JR; SUMMIT Consortium; Janes S. Prevalence and clinical characteristics of non-malignant CT detected incidental findings in the SUMMIT lung cancer screening cohort. BMJ Open Respir Res. 2023 Jun;10(1):e001664. doi: 10.1136/bmjresp-2023-001664.
Dickson JL, Hall H, Horst C, Tisi S, Verghese P, Mullin AM, Teague J, Farrelly L, Bowyer V, Gyertson K, Bojang F, Levermore C, Anastasiadis T, McCabe J, Navani N, Nair A, Devaraj A, Hackshaw A, Quaife SL, Janes SM; SUMMIT consortium. Uptake of invitations to a lung health check offering low-dose CT lung cancer screening among an ethnically and socioeconomically diverse population at risk of lung cancer in the UK (SUMMIT): a prospective, longitudinal cohort study. Lancet Public Health. 2023 Feb;8(2):e130-e140. doi: 10.1016/S2468-2667(22)00258-4.
Bhamani A, Horst C, Bojang F, Quaife SL, Dickson JL, Tisi S, Hall H, Verghese P, Creamer A, Prendecki R, McCabe J, Gyertson K, Bowyer V, El-Emir E, Cotton A, Mehta S, Levermore C, Mullin AM, Teague J, Farrelly L, Nair A, Devaraj A, Hackshaw A; SUMMIT consortium; Janes SM. The SUMMIT Study: Utilising a written 'Next Steps' information booklet to prepare participants for potential lung cancer screening results and follow-up. Lung Cancer. 2023 Feb;176:75-81. doi: 10.1016/j.lungcan.2022.12.006. Epub 2022 Dec 24.
Creamer AW, Horst C, Dickson JL, Tisi S, Hall H, Verghese P, Prendecki R, Bhamani A, McCabe J, Gyertson K, Mullin AM, Teague J, Farrelly L, Hackshaw A, Nair A; SUMMIT consortium; Devaraj A, Janes SM. Growing small solid nodules in lung cancer screening: safety and efficacy of a 200 mm3 minimum size threshold for multidisciplinary team referral. Thorax. 2023 Feb;78(2):202-206. doi: 10.1136/thorax-2022-219403. Epub 2022 Nov 25.
Dickson JL, Bhamani A, Quaife SL, Horst C, Tisi S, Hall H, Verghese P, Creamer A, Prendecki R, McCabe J, Gyertson K, Bowyer V, El-Emir E, Cotton A, Mehta S, Bojang F, Levermore C, Mullin AM, Teague J, Farrelly L, Nair A, Devaraj A, Hackshaw A, Janes SM; SUMMIT consortium. The reporting of pulmonary nodule results by letter in a lung cancer screening setting. Lung Cancer. 2022 Jun;168:46-49. doi: 10.1016/j.lungcan.2022.04.009. Epub 2022 Apr 20.
Other Identifiers
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UCL/17/0050
Identifier Type: -
Identifier Source: org_study_id