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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 : Enrolling by invitation
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
GRAIL, Inc.
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Brief Summary:
The SUMMIT Study will enrol 50,000 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 and east London.

Condition or disease Intervention/treatment
Cancer Lung Cancer Radiation: Low Dose CT scan

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 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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Group B
25,000 individuals who are not at high-risk for smoking-related cancers .



Primary Outcome Measures :
  1. 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
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.


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   50 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SUMMIT plans to enrol 50,000 participants, aged 50 - 77 years, from participating 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 (Group A). The other half will be people who are not at high-risk for smoking-related cancers (Group B).
Criteria

Inclusion Criteria:

- Group A

  1. Individuals 50 to 77 years old 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. Willing to comply with the protocol

Group B

  1. Individuals 50 to 77 years old
  2. Individuals who do not meet the criteria for Group A.

Exclusion Criteria:

  • Group A
  • 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).
  • Pregnancy.

Group B

  • 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).
  • Meets eligibility criteria for Group A.

Information from the National Library of Medicine

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


Locations
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United Kingdom
UCLH
London, United Kingdom
Sponsors and Collaborators
University College, London
GRAIL, Inc.
University College London Hospitals
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03934866    
Other Study ID Numbers: UCL/17/0050
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes