Early Cancer Detection Test - Lung Cancer Scotland (ECLS)

Stuart Schembri

Status: Completed

Conditions: Lung Cancer

Treatments: Biological: Early CDT Lung blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT01925625

2013ON07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,210 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,210 participants in 2 patient groups

Control

No Intervention group

Description:

participants monitored for 10 years for lung cancer incidence.

Early CDT Lung Test

Active Comparator group

Description:

Early CDT lung blood test

Treatment:

Biological: Early CDT Lung blood test