Generation Of a Lung Biobank for Future Use | NCT05234138

Studies
Generation Of a Lung Biobank for Future Use

NCT05234138

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Feb 10, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Cancer
Lung Cancer

Interventions

Blood Sample

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2019Actual

Primary Completion Date

Oct 31, 2022Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Feb 8, 2022

First Posted Date

Feb 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2022

Last Update Posted Date

Feb 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim is to invite 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer, referred to The Royal Marsden NHS Foundation Trust (RMH) referral centres (Kingston Hospital NHS Foundation Trust, Epsom and St Helier University Hospitals NHS Trust, Croydon University Hospitals NHS Foundation Trust or St George's University Hospitals NHS Foundation Trust) over a 1 year period, to complete a life style questionnaire, document lung function tests and to donate a blood sample for storage with a view to testing for a genetic signature and other biomarkers in future studies from this established biobank.

Detailed Description

Patients will have been referred under the two week rule (TWR) diagnostic pathway, some will have lung cancer, others not, and other patients will have had a diagnosis of lung cancer by other pathways i.e. non TWR.

There are 3 groups of patients:

Group A - lung cancer patients at any stage and by any non TWR pathway, n=250. Group B - lung cancer patients who were referred initially by the TWR pathway, n=150.

Group C - Subjects referred by the TWR pathway (i.e. with symptoms) who do not have lung cancer, or subjects referred by any pathway who do not have lung cancer but do have radiological changes (that need follow up) or a strong family history of lung cancer, n=600.

A strong family history for this study means 1 or more first degree relatives with lung cancer with at least one individual having lung cancer at age <50 yrs.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blood Sample	Other	Blood Sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Create a collection of blood samples in a Biobank for Future Use	The aim is to ask 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer and to create a collection of blood samples in a Biobank for Future Use.	3 Years
Feasibility as a Primary Endpoint	Feasibility will be reported as the primary endpoint, where we expect 50% of patients would be willing to give a blood sample- i.e. 250/year for 2 years and thus a biobank will be established.	3 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

One of the following criteria:

Patients with lung cancer at any stage or time in their disease.
Patients without lung cancer who have been referred by the TWR pathway.
Patients without lung cancer who have radiological changes on their X-Ray or CT scan that need follow up.
Patients without lung cancer who have a strong family history of lung cancer. PLUS
Patients aged >18 Years
Patients who have signed informed consent form

Exclusion Criteria:

Unable to provide informed consent.
Bleeding disorder or other medical condition that would make a blood sample hazardous.
Within 3 weeks of chemotherapy or radiotherapy (as low lymphocyte may be associated with poor DNA yield).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Royal Marsden Hospital NHS Foundation Trust (Sutton and Chelsea)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mary O'Brien	Contact	020 8642 6011		Lung.Trials@rmh.nhs.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden Hospital NHS Foundation Trust	Recruiting	London		SW3 6JJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided