Comparison of Longer-term (5 Year+) Outcomes (Survival) o... | NCT07127263

Studies
Comparison of Longer-term (5 Year+) Outcomes (Survival) of Smokers, Ex-smokers, Never Smoker and Quitters

NCT07127263

Sponsor

Hywel Dda Health Board

Status

Completed

Last Update Posted

Aug 17, 2025Actual

Enrollment

525Actual

Phase

Not provided

Conditions

Lung Cancer - Non Small Cell Squamous

Interventions

Not provided

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

Official Title

Comparison of Longer Term Outcomes Following the LungCast "Smoking Cessation in Lung Cancer Study". Revisiting the Original LungCast Research Cohort to Look at Longer-term Outcomes (5+ Years) in Newly Diagnosed Lung Cancer, Within Hywel Dda University Health Board Participants Only, Who Were Smokers, Ex-smokers, Never Smoker and Quitters.

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2024Actual

Primary Completion Date

Feb 4, 2025Actual

Completion Date

May 30, 2025Actual

First Submitted Date

May 7, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 17, 2025Actual

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

Aug 11, 2025

Last Update Posted Date

Aug 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Between 2010-2020, the LungCAst observational study followed 3700 patients newly diagnosed with lung cancer across 33 hospitals in Wales and England for 2 years to see if smoking status at time of diagnosis predicted survival rate. This research was sponsored and led by Hywel Dda University Health Board (HDUHB).

This new study examines the health records, (of only the HDUHB participants included in the original LungCAst study), over a longer period of time to see if the benefits of stopping smoking at point of diagnosis with lung cancer continues over a longer period of time (5 years+).

Detailed Description

A study into longer-term outcomes from the LUNGCAST study: comparing survival and healthcare utilisation according to smoking status in people with lung cancer, beyond 2 years. By obtaining Hospital Episode Statistics (HES) extract from the Welsh Patient Administration System (WPAS) and Welsh Clinical Portal (WCP) the investigators can retrospectively follow the cohort participants over time and analyse health care utilisation activity, using univariate and multivariate analysis on the effect of smoking status on survival. The Kaplan-Meier method, will be used to estimate the probability of survival over time.

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

No data available

No data is available for this block.

Enrollment

525Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnosed Lung Cancer		Patients diagnosed with Lung Cancer, with smoking status recorded at time of diagnosis.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of longer-term (5 year+) outcomes (survival) of smokers, ex-smokers and never smokers diagnosed with lung cancer between 2010 and 2020	Following participants with lung cancer over a 5 year period, by reviewing ongoing healthcare activity via HES extraction and applying the Kaplan-Meier method, to evaluate if smoking status at diagnosis predicts better survival rates over a longer period of time. Univariate and multivariate analysis on the effect of smoking status on survival will also be applied.	From date of diagnosis (of having lung cancer) for 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients from the Hywel Dda University Health Board's(HDUHB) site that participated in the original LungCast study

Exclusion Criteria:

Individuals that did not participate in the original LungCast study in the HDUHB site.

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

Patients from the Hywel Dda University Health Board's (HDUHB) site that participated in the original LungCast study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hywel Dda University Health Board		Carmarthen	Carmarthenshire	SA31 3BB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided