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Early Cancer Detection Test - Lung Cancer Scotland (ECLS)

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ClinicalTrials.gov Identifier: NCT01925625
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Stuart Schembri, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Early CDT Lung blood test Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test
Study Start Date : August 2013
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
No Intervention: Control
participants monitored for 10 years for lung cancer incidence.
Active Comparator: Early CDT Lung Test
Early CDT lung blood test
Biological: Early CDT Lung blood test
The EarlyCDT-Lung Test is an early detection test designed to assist in lung cancer risk assessment and detection in the earliest stages of the disease.
Other Name: EarlyCDT-Lung test




Primary Outcome Measures :
  1. 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; [ Time Frame: 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;



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925625


Locations
United Kingdom
NHS Tayside
Dundee, Tayside, United Kingdom, DD1 9SY
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
NHS Lanarkshire
Wishaw, United Kingdom
Sponsors and Collaborators
Stuart Schembri
Investigators
Principal Investigator: Frank Sullivan, MbChB University of Dundee

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stuart Schembri, Consultant, University of Dundee
ClinicalTrials.gov Identifier: NCT01925625     History of Changes
Other Study ID Numbers: 2013ON07
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: paticipant activity nearing closure

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases