The SUMMIT Study: A Cancer Screening Study (SUMMIT)
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|ClinicalTrials.gov Identifier: NCT03934866|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : November 8, 2022
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|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 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.
|Study Type :||Observational|
|Actual Enrollment :||13035 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.
- 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. [ Time Frame: 12 months ]
Cancer incidence associated with screening test performance:
- False positive rate (1-specificity), specificity
- Positive predictive value (PPV)
- Negative predictive value (NPV)
- 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). [ Time Frame: 36 months ]
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
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||55 Years to 77 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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
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).
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|
|Responsible Party:||University College, London|
|Other Study ID Numbers:||
|First Posted:||May 2, 2019 Key Record Dates|
|Last Update Posted:||November 8, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|