The SUMMIT Study: A Cancer Screening Study (SUMMIT)
|ClinicalTrials.gov Identifier: NCT03934866|
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment|
|Cancer Lung Cancer||Radiation: Low Dose CT scan|
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.
SUMMIT plans to enrol 50,000 participants aged 50 - 77 years, from participating general practitioner (GP) practices in north and east London. Half of the participants will be people who are at high-risk for lung cancer due to a significant smoking history based on validated risk scores (Group A). The other half will be people who are not at high-risk for smoking-related cancers (Group B).
Group A: 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.
Group B: Individuals who do not have a significant smoking history will be invited to attend an appointment where they will be provided with information about the study and their eligibility for participation will be assessed. If they consent to take part in the study (electronic informed consent), they will provide a blood sample and complete a confidential electronic questionnaire. Participants will be asked to return for two further annual visits to provide a blood sample and complete a confidential questionnaire.
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.
|Study Type :||Observational|
|Estimated Enrollment :||50000 participants|
|Official Title:||The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test|
|Actual Study Start Date :||April 8, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2030|
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
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.
25,000 individuals who are not at high-risk for smoking-related cancers .
- Cancer Incidence [ Time Frame: First Year ]
Endpoints associated with screening service performance measures:
- number of screen-detected cancers per 1000 screened (and number needed to screen to detect 1 cancer)
- number of early stage screen-detected cancers per 1000 screened (and number needed to screen to detect 1 early stage cancer)
- number of people referred for diagnostic investigations per 1000 screened
- number of people who have a biopsy per 1000 screened
- the malignant:benign biopsy ratio
- incidence per 1000 per year
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934866
|London, United Kingdom|