'Lung Health Check' Biomarker Study

NCT04957433 | Unknown

• 1 other identifier: CCR5067
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

CT screening of lung cancer offers an opportunity to diagnose early stage lung cancers which is associated with better prognosis - indeterminate results delay diagnosis whilst interval imaging is awaited to assess risk of cancer. This study will allow us to examine the potential of blood-based biomarkers to augment CT screening for lung cancer. Hypotheses

1. 1.Blood and sputum samples can be collected in patients attending lung health checks as part of the Lung Health Check pilot in West London at fixed and mobile scanners and safely transported for processing and storage in preparation for biomarker development.
2. 2.The biomarkers will help to identify cohorts of
3. 3.High-risk patients in whom CT surveillance should be conducted more readily/frequently and diagnostic procedures performed earlier.
4. 4.Low-risk patients who might need reduced surveillance intensity.
5. 5.Patients with interstitial lung abnormalities that share similar biomarker characteristics to patients with clinically significant interstitial lung disease

Conditions

Lung Cancer; Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of the primary objective to collate a lung health check biobank

  The feasibility of the primary objective to collate a lung health check biobank will be reported as a percentage after the final participant recruited has donated both a baseline sample and also their final specimen (or on the same date should they decline to do so). The primary end point of the project will be considered feasible if consent to a blood test, collection and storage can be achieved in at least 50% of the 1000 patients approached for the biomarker study who undertake an LDCT scan.

  2 Years

Secondary Outcomes (3)

• Confirming if a lung cancer genomics panel differs between participants who receive a diagnosis of lung cancer at the time of the baseline scan and those who do not

  2 Years

• Confirming if a lung cancer genomics panel (taken at baseline LDCT screening scans) differs between those who receive a diagnosis of lung cancer and those who do not after completion of follow-up imaging

  2 years

• Confirming if peripheral blood telomere length can determine those who have interstitial lung abnormalities at those who do not, and who is at higher risk of developing overt pulmonary fibrosis

  2 years

Other Outcomes (2)

• Are sputum and blood specimens of suitable volume and quality for given proposed laboratory biomarker tests

  2 Years

• Do given biomarker panels differ between patients who receive a diagnosis of lung cancer and those who do not.

  2 years

Study Arms (4)

Cohort A

Patients new to The Lung Health Check (TLHC) pilot who are attending their first lung health check

Diagnostic Test: Blood Specimen

Cohort B (Nodule Suveillance)

Patients who have already undergone one lung health check as part of the TLHC programme, and are now being followed up at 3 months (B1), 12 months (B2) or other (BX) due to an indeterminate finding (e.g. lung nodule)

Diagnostic Test: Blood Specimen

Cohort C (Incident Scan)

Patients who are already part of TLHC attending for routine 'incident' round follow-up scanning (usually at approximately 24 months)

Diagnostic Test: Blood Specimen

Cohort D

Participants with interstitial lung abnormalities (ILAs) identified as part of TLHC, who are referred to the interstitial lung disease (ILD) unit at Royal Brompton Hospital.

Diagnostic Test: Blood Specimen

Interventions

Blood Specimen DIAGNOSTIC_TEST

Blood and Sputum Specimen Samples

Also known as: Sputum Specimen

Cohort A; Cohort B (Nodule Suveillance); Cohort C (Incident Scan); Cohort D

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had been identified using two lung cancer risk calculators, the modified Liverpool Lung Project (LLPv2) and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) to be at high risk for lung cancer and recruited to The Lung Health Check (TLHC) pilot taking place in West London.

You may qualify if:

• Patients invited to participate in the Royal Marsden (RM) Partners Lung Health Check pilot study who undergo one or more CT scans:
• Between the age of 55-75 years of age; and
• Current smokers or ex-smokers who have quit after the age of 40.

You may not qualify if:

• Patients excluded from the Lung Health Check:
• On the palliative care register;
• Any active malignancy undergoing treatment
• Daily activity levels equivalent to performance score 3 or 4; and
• Unable to consent to Lung Health Check Biomarker Study

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Imperial College London: collaborator
• Royal Marsden Partners Cancer Alliance: collaborator

Study Sites (1)

The Royal Brompton NHS Foundation Trust

London, SW3 6NP, United Kingdom

RECRUITING

Related Publications (5)

• Cohen JD, Li L, Wang Y, Thoburn C, Afsari B, Danilova L, Douville C, Javed AA, Wong F, Mattox A, Hruban RH, Wolfgang CL, Goggins MG, Dal Molin M, Wang TL, Roden R, Klein AP, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Vogelstein JT, Browne JD, Schoen RE, Brand RE, Tie J, Gibbs P, Wong HL, Mansfield AS, Jen J, Hanash SM, Falconi M, Allen PJ, Zhou S, Bettegowda C, Diaz LA Jr, Tomasetti C, Kinzler KW, Vogelstein B, Lennon AM, Papadopoulos N. Detection and localization of surgically resectable cancers with a multi-analyte blood test. Science. 2018 Feb 23;359(6378):926-930. doi: 10.1126/science.aar3247. Epub 2018 Jan 18.

  PMID: 29348365 RESULT

• Wang BH, Li YY, Han JZ, Zhou LY, Lv YQ, Zhang HL, Zhao L. Gene methylation as a powerful biomarker for detection and screening of non-small cell lung cancer in blood. Oncotarget. 2017 May 9;8(19):31692-31704. doi: 10.18632/oncotarget.15919.

  PMID: 28404957 RESULT

• Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.

  PMID: 24705333 RESULT

• Ye M, Li S, Huang W, Wang C, Liu L, Liu J, Liu J, Pan H, Deng Q, Tang H, Jiang L, Huang W, Chen X, Shao D, Peng Z, Wu R, Zhong J, Wang Z, Zhang X, Kristiansen K, Wang J, Yin Y, Mao M, He J, Liang W. Comprehensive targeted super-deep next generation sequencing enhances differential diagnosis of solitary pulmonary nodules. J Thorac Dis. 2018 Apr;10(Suppl 7):S820-S829. doi: 10.21037/jtd.2018.04.09.

  PMID: 29780628 RESULT

• Zhao H, Chen KZ, Hui BG, Zhang K, Yang F, Wang J. Role of circulating tumor DNA in the management of early-stage lung cancer. Thorac Cancer. 2018 May;9(5):509-515. doi: 10.1111/1759-7714.12622. Epub 2018 Mar 12.

  PMID: 29528556 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Lee

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Lee

CONTACT

02086613566; richard.lee@rmh.nhs.uk

Sejal Jain

CONTACT

0203 186 5316; sejal.jain@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: July 12, 2021
• Study Start: September 28, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)