The SUMMIT Study: A Cancer Screening Study

NCT03934866 | Active Not Recruiting DMC

• 1 other identifier: UCL/17/0050
• Study Type: observational
• Target: 13,035
• Locations: 1 country
• Sites: 1

Brief Summary

The SUMMIT Study will enrol 13,000 participants in order to investigate how cancer screening can be improved and delivered. The SUMMIT Study has two main aims: the first is to clinically validate a blood test for detecting multiple cancers at an early stage. The second is to examine the feasibility of delivering a low-dose CT (LDCT) screening service for lung cancer to a high-risk population in North Central and East London.

Conditions

Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the performance of the cell-free nucleic acid (cfNA) signals measured using high-intensity sequencing (ultra-deep and ultra-broad) for the detection of invasive cancer and identification of tissue of cancer origin using a GRAIL blood test.

  Cancer incidence associated with screening test performance: * Sensitivity * False positive rate (1-specificity), specificity * Positive predictive value (PPV) * Negative predictive value (NPV)

  12 months

• To examine the performance of delivering a Low-Dose Computed Tomography (LDCT) screening service using established measures of performance and risk prediction of lung cancers and other incidental findings (see the performance indicators measured below).

  Performance indicators that will be measured include the number of: * eligible participants who choose to have an LDCT. * characteristics of those who choose to have LDCT, e.g. age, sex, ethnicity, area-level deprivation score and smoking status. * people who have a baseline LDCT who attend at year 1 and also at year 2. * screen-detected cancers per 1000 screened * early stage screen-detected cancers per 1000 screened * late stage screen-detected cancers per 1000 screened * people referred for diagnostic investigations per 1000 screened * people who have a biopsy per 1000 screened * malignant and benign tumours detected * incidence per 1000 per year

  36 months

Study Arms (1)

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.

Radiation: Low Dose CT scan

Interventions

Low Dose CT scan RADIATION

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.

Group A (LDCT)

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SUMMIT plans to enrol 13,000 participants, aged 55-77 years, from participating GP practices in north and east London who are at high-risk for lung cancer due to a significant smoking history.

You may qualify if:

• Individuals 55 to 77 years old at the time of GP data extraction, who meet either of the following criteria:
• 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
• PLCOm2012 6-year lung cancer risk of ≥1.3%
• Capable of providing informed consent and willing to comply with all parts of the protocol

You may not qualify if:

• Currently receiving treatment (e.g., chemotherapy, radiotherapy, watchful waiting) for an active cancer. If on adjuvant hormonal therapy can be included (e.g. for breast and prostate cancer).

Sponsors & Collaborators

• University College, London: lead
• GRAIL, Inc.: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

UCLH

London, United Kingdom

Location

Related Publications (7)

• Mullin ML, Verghese P, Khaw CR, Creamer A, Bhamani A, Prendecki R, Dickson JL, Horst C, Tisi S, Hall H, Gyertson K, Arthur-Darkwa E, Farrelly L, McCabe J, Thakrar R, Nair A, Devaraj A, Navani N, Hackshaw A; SUMMIT consortium; Janes SM. Upstaging of screen-detected lung cancers during diagnostic assessment. Thorax. 2026 Feb 2:thorax-2025-224006. doi: 10.1136/thorax-2025-224006. Online ahead of print.

  PMID: 41629156 DERIVED

• 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.

  PMID: 40154514 DERIVED

• 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.

  PMID: 37321665 DERIVED

• 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.

  PMID: 36709053 DERIVED

• 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.

  PMID: 36621036 DERIVED

• 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.

  PMID: 36428100 DERIVED

• 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.

  PMID: 35487105 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken at each visit and sent to GRAIL to clinically validate a blood test for detecting multiple cancers at an early stage. An additional blood sample will be collected for (and stored by) UCL for future research.

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: April 8, 2019
• Primary Completion: May 1, 2025
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

GB (1)