Early Cancer Detection Test - Lung Cancer Scotland

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Biological: Early CDT Lung blood test

• Registration Number: NCT01925625
• Lead Sponsor: Stuart Schembri

Brief Summary

HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.

Detailed Description

AIMS To assess the effectiveness of EarlyCDT-Lung test in increasing early stage lung cancer detection, thereby reducing the rate of late stage (3 / 4 / U) presentation, compared to normal clinical practice; to assess the cost-effectiveness of EarlyCDT-Lung test compared to normal clinical practice; to assess the effectiveness of EarlyCDT-Lung test in reducing adverse outcomes including potential psychological and behavioural consequences.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12210

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female aged 50 years to 75 years
3. Current or Ex-smoker with at least 20 year pack history
4. or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)
5. ECOG Status: 0, 1 and 2 (Eastern Co-operative Oncology Group) Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
6. Geographical postal sectors of:

NHS Geographical Area Eligible Postcodes Tayside DD1 - DD11, PH1-PH3 , PH6-PH8, PH10, PH11, PH13, PH15 & PH16 Greater Glasgow & Clyde G1-G5, G11 -G15, G20-G22, G31-34, G40 -G46, G51- G53, G60-G62 &G64, G66 & G69, G72 & G73, G76-G78, G81-G83 PA1-PA8 (except PA6), PA11-PA16 & PA19

Exclusion Criteria

1. History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.
2. Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).
3. Patients for whom the GP considers invitation to the study would cause undue distress.
4. Patients with other terminal disease.
5. Patients on prolonged / continuous use (> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early CDT Lung Test	Early CDT Lung blood test	Early CDT lung blood test

Primary Outcome Measures

Name	Time	Method
to assess the effectiveness of EarlyCDT-Lung test in reducing the incidence of patients with late-stage lung cancer at diagnosis, compared with standard clinical practice;	24 months	difference at 24 months after randomisation, between the number of patients with stage 3, 4 or unclassified lung cancer at diagnosis in the intervention arm, and those in the control arm;

Trial Locations

Locations (3)

NHS Greater Glasgow & Clyde; 🇬🇧 Glasgow, United Kingdom

NHS Tayside; 🇬🇧 Dundee, Tayside, United Kingdom

NHS Lanarkshire; 🇬🇧 Wishaw, United Kingdom