CancerSUMMITNCT03934866
The SUMMIT Study: A Cancer Screening Study
An observational study of Cancer and Lung Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Lung Cancer
- What is being tested?
- Low Dose CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 13,035 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2019to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test
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.
Read the 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 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.
- Conditions
- Cancer, Lung Cancer
- Being tested
- Low Dose CT scan
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose CT scanRadiation
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Low Dose CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Cancer incidence associated with screening test performance:
- Sensitivity
- False positive rate (1-specificity), specificity
- Positive predictive value (PPV)
- Negative predictive value (NPV)
Measured: 12 months
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).
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start8 Apr 2019
- Primary completionMay 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- GRAIL, Inc., University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934866
- Sponsor's protocol ID
- UCL/17/0050
- Acronym
- SUMMIT
- Status last verified
- Dec 2024
- First submitted
- 26 Apr 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaja S, Dickson JL, Horst C, Mullin ML, Bhamani A, Creamer A, Hall H, Khaw CR, Prendecki R, Verghese P, Tisi S, McCabe J, Arthur-Darwka E, Navani N, Devaraj A, Nair A; SUMMIT consortium; Janes SM, Hackshaw A. The effect of cigar, cigarillo and pipe smoking on lung cancer risk and screening eligibility. Br J Cancer. 2026 Aug 7. doi: 10.1038/s41416-026-03578-9. Online ahead of print.
PubMed 42567897Mullin ML, Verghese P, Khaw CR, Creamer A, Bhamani A, Prendecki R, Dickson JL, Horst C, Tisi S, Hall H, Gyertson K, Arthur-Darkwa E, Farrelly L, McCabe J, Thakrar R, Nair A, Devaraj A, Navani N, Hackshaw A; SUMMIT consortium; Janes SM. Upstaging of screen-detected lung cancers during diagnostic assessment. Thorax. 2026 Aug 14;81(9):894-902. doi: 10.1136/thorax-2025-224006.
PubMed 41629156Bhamani 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.
PubMed 40154514Aslani S, Alluri P, Gudmundsson E, Chandy E, McCabe J, Devaraj A, Horst C, Janes SM, Chakkara R, Alexander DC; SUMMIT consortium; Nair A, Jacob J. Enhancing cancer prediction in challenging screen-detected incident lung nodules using time-series deep learning. Comput Med Imaging Graph. 2024 Sep;116:102399. doi: 10.1016/j.compmedimag.2024.102399. Epub 2024 May 20.
PubMed 38833895Tisi 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.
PubMed 37321665Dickson 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.
PubMed 36709053Bhamani 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.
PubMed 36621036Creamer 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.
PubMed 36428100Dickson 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.
PubMed 35487105
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUMMIT Study: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-cancer Early Detection Test
- ClinicalTrials.gov ID
- NCT03934866
- Acronym / sponsor ID
- SUMMIT / UCL/17/0050
- Conditions
- Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13,035 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- GRAIL, Inc., University College London Hospitals
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A (LDCT) | – | Radiation: Low Dose CT scan25,000 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. |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Individuals 55 to 77 years old at the time of GP data extraction, who meet either of the following criteria:
- Capable of providing informed consent and willing to comply with all parts of the protocol
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose CT scanLow 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. | Radiation | Group A (LDCT) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 42567897Vaja S, Dickson JL, Horst C, Mullin ML, Bhamani A, Creamer A, Hall H, Khaw CR, Prendecki R, Verghese P, Tisi S, McCabe J, Arthur-Darwka E, Navani N, Devaraj A, Nair A; SUMMIT consortium; Janes SM, Hackshaw A. The effect of cigar, cigarillo and pipe smoking on lung cancer risk and screening eligibility. Br J Cancer. 2026 Aug 7. doi: 10.1038/s41416-026-03578-9. Online ahead of print.
- Derived from this study: PubMed 41629156Mullin ML, Verghese P, Khaw CR, Creamer A, Bhamani A, Prendecki R, Dickson JL, Horst C, Tisi S, Hall H, Gyertson K, Arthur-Darkwa E, Farrelly L, McCabe J, Thakrar R, Nair A, Devaraj A, Navani N, Hackshaw A; SUMMIT consortium; Janes SM. Upstaging of screen-detected lung cancers during diagnostic assessment. Thorax. 2026 Aug 14;81(9):894-902. doi: 10.1136/thorax-2025-224006.
- Derived from this study: PubMed 40154514Bhamani 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.
- Derived from this study: PubMed 38833895Aslani S, Alluri P, Gudmundsson E, Chandy E, McCabe J, Devaraj A, Horst C, Janes SM, Chakkara R, Alexander DC; SUMMIT consortium; Nair A, Jacob J. Enhancing cancer prediction in challenging screen-detected incident lung nodules using time-series deep learning. Comput Med Imaging Graph. 2024 Sep;116:102399. doi: 10.1016/j.compmedimag.2024.102399. Epub 2024 May 20.
- Derived from this study: PubMed 37321665Tisi 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.
- Derived from this study: PubMed 36709053Dickson 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.
- Derived from this study: PubMed 36621036Bhamani 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.
- Derived from this study: PubMed 36428100Creamer 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.
- Derived from this study: PubMed 35487105Dickson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Lung Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934866, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.