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The SUMMIT Study: A Cancer Screening Study (SUMMIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934866
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : May 19, 2021
Sponsor:
Collaborators:
GRAIL, Inc.
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date April 26, 2019
First Posted Date May 2, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date April 8, 2019
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2020)
  • 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:
    • Sensitivity
    • 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
Original Primary Outcome Measures
 (submitted: April 30, 2019)
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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The SUMMIT Study: A Cancer Screening Study
Official Title The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test
Brief Summary The SUMMIT Study will enrol 25,000 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.
Detailed Description

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 25,000 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population SUMMIT plans to enrol 25,000 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.
Condition
  • Cancer
  • Lung Cancer
Intervention 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.
Study Groups/Cohorts 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.

Intervention: Radiation: Low Dose CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 17, 2021)
13035
Original Estimated Enrollment
 (submitted: April 30, 2019)
50000
Estimated Study Completion Date August 2030
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 (or at least 20 years duration), 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).

Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934866
Other Study ID Numbers UCL/17/0050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators
  • GRAIL, Inc.
  • University College London Hospitals
Investigators Not Provided
PRS Account University College, London
Verification Date May 2021