Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT03934866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2019-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SUMMIT Study: A Cancer Screening Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13035}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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:\n\n* Sensitivity\n* False positive rate (1-specificity), specificity\n* Positive predictive value (PPV)\n* 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).', 'timeFrame': '36 months', 'description': 'Performance indicators that will be measured include the number of:\n\n* eligible participants who choose to have an LDCT.\n* characteristics of those who choose to have LDCT, e.g. age, sex, ethnicity, area-level deprivation score and smoking status.\n* people who have a baseline LDCT who attend at year 1 and also at year 2.\n* screen-detected cancers per 1000 screened\n* early stage screen-detected cancers per 1000 screened\n* late stage screen-detected cancers per 1000 screened\n* people referred for diagnostic investigations per 1000 screened\n* people who have a biopsy per 1000 screened\n* malignant and benign tumours detected\n* incidence per 1000 per year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40154514', 'type': 'DERIVED', 'citation': "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': '37321665', 'type': 'DERIVED', 'citation': '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': '36709053', 'type': 'DERIVED', 'citation': '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': '36621036', 'type': 'DERIVED', 'citation': "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': '36428100', 'type': 'DERIVED', 'citation': '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': '35487105', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The SUMMIT Study is a prospective, observational, cohort study. Its aim is to clinically validate a blood test for the early detection of multiple types of cancer, and to deliver LDCT screening for lung cancer to an at-risk population.\n\nSUMMIT 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.\n\nIndividuals 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).\n\nIf 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.\n\nThere 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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals 55 to 77 years old at the time of GP data extraction, who meet either of the following criteria:\n\n 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\n 2. PLCOm2012 6-year lung cancer risk of ≥1.3%\n2. Capable of providing informed consent and willing to comply with all parts of the protocol\n\nExclusion Criteria:\n\nCurrently 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).'}, 'identificationModule': {'nctId': 'NCT03934866', 'acronym': 'SUMMIT', 'briefTitle': 'The SUMMIT Study: A Cancer Screening Study', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test', 'orgStudyIdInfo': {'id': 'UCL/17/0050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A (LDCT)', 'description': '25,000 individuals who are at high-risk for lung cancer due to a significant smoking history.\n\nParticipants will receive at least 1 LDCT scan at baseline.', 'interventionNames': ['Radiation: Low Dose CT scan']}], 'interventions': [{'name': 'Low Dose CT scan', 'type': 'RADIATION', 'description': '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.', 'armGroupLabels': ['Group A (LDCT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'UCLH', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'GRAIL, Inc.', 'class': 'INDUSTRY'}, {'name': 'University College London Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}