Lung CancerLungExoDETECTNCT04629079
Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging
An observational study of Lung Cancer, run by King's College London at 1 site in United Kingdom.
Trial summary
This project aims to validate exosomal assays that are based on hypoxia detection as potential biomarkers of early detection. The study analysis will determine whether the assay can detect clinical lung cancer at the time of imaging and interval cancers during subsequent follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2020to 23 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients who have been referred to the Lung Cancer Clinic and Multi- Disciplinary Team (MDT) at The Lister, Hertford County and New QEII Hospitals for investigation of suspected lung cancer.
Who may be able to join
- Over 18 years of age
- Suspected clinical diagnosis of lung cancer
- Able to provide informed consent
Who cannot join
- -Synchronous other cancer types.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Borthwick Research Unit, Lister Hospital
Stevenage, SG1 4AB
Carina Cruz, MRes
About this study
Official title: Lung Cancer Detection Using Blood Exosomes and HRCT- Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging
This project aims to validate exosomal assays that are based on hypoxia detection as potential biomarkers of early detection. The study analysis will determine whether the assay can detect clinical lung cancer at the time of imaging and interval cancers during subsequent follow up. The study aims to establish preliminary sensitivity/specificity data for the "combined CT/exosomal risk stratification marker" and provide initial data on the potential association of the "combined CT/exosomal risk score" with the subsequent cancer progression and treatment response.
Read the detailed description
Lung cancer is the leading cause of cancer deaths. Screening for early detection of cancer at an early stage reduces cancer deaths and therefore improves prognosis. The National Lung Screening Trial (NLST), for instance, showed that CT screening increases the early detection rate, and reduces mortality. However, drawbacks include over-diagnosis, false-positive results, psychological distress and cost. Therefore, lung cancer screening is not recommended or available within the NHS.
Diagnosis of lung cancer is currently based on a combination of scans and tissue biopsy. The invasive nature of current diagnostic procedures limits their application. To improve the efficacy and cost effectiveness of screening in early detection of lung cancer, additional, complementary and non-invasive methods, such as circulating biomarkers, should be evaluated. Our novel exosomal assay (taken from a blood sample) when combined with CT, may improve the current accuracy of lung cancer detection, especially that of a worse clinical prognosis. Improvement in the accuracy of detection and/or prediction of future disease by performing the combined imaging exosome test will cause a paradigm shift. Moving towards the identification of blood tests can help increase confidence about follow-up decisions and shorten the interval before biopsy.
This prospective cohort study will recruit patients referred to secondary care for the investigation of clinical symptoms or signs suspicious of lung cancer.
The study will run between 2020 and 2024 (two-year active recruitment and two-year follow up).
Participants will have a single assay of blood taken on one occasion in the lung clinic by trained staff.
Participants will have normal standard of care chest CT scans and this data will be used.
All participants will be actively followed for 3 months and then those with nodules, revealed by CT Scan, at 3 monthly intervals. Longitudinal clinical data will be collected on the investigations, diagnoses and outcomes of all study patients.
Data will be collected on date, type and results of imaging and biopsy investigations including nodule size and progression.
For those diagnosed with lung cancer, data on tumour size, stage, type and other markers) will be recorded together with treatment response and date of death, where this occurs within the study.
- Conditions
- Lung Cancer
- Keywords
- Early detection
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
Describe the expression of hypoxia- response element (HRE) responsible protein P4HA1 utilising a hypoxia-reporting cancer exosomal assay in participants being clinically assessed for suspected lung cancer.
Measured: Through study completion, an average of 2 years.
Secondary outcomes (2)
Describe the range of expression of precursor microRNA in exosomes derived from participants being clinically assessed for suspected lung cancer and compare the range of expression between the cancer and non-cancer participant population.
Utilise exosome-based assessment of pre-microRNA processing to inform the development of a hypoxia gene signature for the early detection of lung cancer.
Measured: Through study completion, an average of 2 years.
Develop a combined risk score combining multi-dimensional parameters to discriminate between cancer cases and non-cancer cases.
To develop a combined risk prediction model to support the early diagnosis of lung cancer.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start23 Oct 2020
- Primary completion23 Oct 2022 (estimated)
- Study completion23 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by King's 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thida Win, MD, Principal investigator, Lister Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629079
- Sponsor's protocol ID
- 261766
- Acronym
- LungExoDETECT
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Detection Using Blood Exosomes and HRCT- Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging
- ClinicalTrials.gov ID
- NCT04629079
- Acronym / sponsor ID
- LungExoDETECT / 261766
- Conditions
- Lung Cancer
- Keywords
- Early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 23 Oct 2022 (estimated)
- Study completion
- 23 Oct 2024 (estimated)
- First posted
- 16 Nov 2020 (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.
This project aims to validate exosomal assays that are based on hypoxia detection as potential biomarkers of early detection. The study analysis will determine whether the assay can detect clinical lung cancer at the time of imaging and interval cancers during subsequent follow up. The study aims to establish preliminary sensitivity/specificity data for the "combined CT/exosomal risk stratification marker" and provide initial data on the potential association of the "combined CT/exosomal risk score" with the subsequent cancer progression and treatment response.
Detailed description
Lung cancer is the leading cause of cancer deaths. Screening for early detection of cancer at an early stage reduces cancer deaths and therefore improves prognosis. The National Lung Screening Trial (NLST), for instance, showed that CT screening increases the early detection rate, and reduces mortality. However, drawbacks include over-diagnosis, false-positive results, psychological distress and cost. Therefore, lung cancer screening is not recommended or available within the NHS.
Diagnosis of lung cancer is currently based on a combination of scans and tissue biopsy. The invasive nature of current diagnostic procedures limits their application. To improve the efficacy and cost effectiveness of screening in early detection of lung cancer, additional, complementary and non-invasive methods, such as circulating biomarkers, should be evaluated. Our novel exosomal assay (taken from a blood sample) when combined with CT, may improve the current accuracy of lung cancer detection, especially that of a worse clinical prognosis. Improvement in the accuracy of detection and/or prediction of future disease by performing the combined imaging exosome test will cause a paradigm shift. Moving towards the identification of blood tests can help increase confidence about follow-up decisions and shorten the interval before biopsy.
This prospective cohort study will recruit patients referred to secondary care for the investigation of clinical symptoms or signs suspicious of lung cancer.
The study will run between 2020 and 2024 (two-year active recruitment and two-year follow up).
Participants will have a single assay of blood taken on one occasion in the lung clinic by trained staff.
Participants will have normal standard of care chest CT scans and this data will be used.
All participants will be actively followed for 3 months and then those with nodules, revealed by CT Scan, at 3 monthly intervals. Longitudinal clinical data will be collected on the investigations, diagnoses and outcomes of all study patients.
Data will be collected on date, type and results of imaging and biopsy investigations including nodule size and progression.
For those diagnosed with lung cancer, data on tumour size, stage, type and other markers) will be recorded together with treatment response and date of death, where this occurs within the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients who have been referred to the Lung Cancer Clinic and Multi- Disciplinary Team (MDT) at The Lister, Hertford County and New QEII Hospitals for investigation of suspected lung cancer.
Key inclusion criteria (3 listed)
- Over 18 years of age
- Suspected clinical diagnosis of lung cancer
- Able to provide informed consent
Key exclusion criteria (1 listed)
- -Synchronous other cancer types.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
Time frame: Through study completion, an average of 2 years.
Describe the expression of hypoxia- response element (HRE) responsible protein P4HA1 utilising a hypoxia-reporting cancer exosomal assay in participants being clinically assessed for suspected lung cancer.
2 secondary outcomes
Describe the range of expression of precursor microRNA in exosomes derived from participants being clinically assessed for suspected lung cancer and compare the range of expression between the cancer and non-cancer participant population.
Time frame: Through study completion, an average of 2 years.
Develop a combined risk score combining multi-dimensional parameters to discriminate between cancer cases and non-cancer cases.
Time frame: Through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Thida Win, MD principal investigator
Lister Hospital
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 Lung Cancer, run by King's 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 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carina Cruz, MRes (01438 284435, carina.cruz@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population. (time frame: Through study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.