Clinical trial · Observational
The SUMMIT Study: A Cancer Screening Study
The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test
NCT03934866CI-TRIAL-00083368SUMMITactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Dose CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group A (LDCT)
- description
- 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.
- interventionNames
- Radiation: Low Dose CT scan
Primary outcomes (2)
- measure
- 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.
- timeFrame
- 12 months
- description
- Cancer incidence associated with screening test performance: * Sensitivity * False positive rate (1-specificity), specificity * Positive predictive value (PPV) * Negative predictive value (NPV)
- measure
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
Inclusion Criteria: 1. Individuals 55 to 77 years old at the time of GP data extraction, who meet either of the following 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: 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).
References
Publications (9)
- DERIVEDVaja S, Dickson JL, Horst C, Mullin ML, Bhamani A, Creamer A, Hall H, Khaw CR, Prendecki R, Verghese P, Tisi S, McCabe J, Arthur-Darwka E, Navani N, Devaraj A, Nair A; SUMMIT consortium; Janes SM, Hackshaw A. The effect of cigar, cigarillo and pipe smoking on lung cancer risk and screening eligibility. Br J Cancer. 2026 Aug 7. doi: 10.1038/s41416-026-03578-9. Online ahead of print. PMID 42567897
- DERIVEDMullin 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 Aug 14;81(9):894-902. doi: 10.1136/thorax-2025-224006. PMID 41629156
- DERIVEDBhamani 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
- DERIVEDAslani S, Alluri P, Gudmundsson E, Chandy E, McCabe J, Devaraj A, Horst C, Janes SM, Chakkara R, Alexander DC; SUMMIT consortium; Nair A, Jacob J. Enhancing cancer prediction in challenging screen-detected incident lung nodules using time-series deep learning. Comput Med Imaging Graph. 2024 Sep;116:102399. doi: 10.1016/j.compmedimag.2024.102399. Epub 2024 May 20. PMID 38833895
- DERIVEDTisi 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.