Early Cancer Detection Test – Lung Cancer Scotland

  • Clinical Studies
  • Dundee

NIHR

uk clinical practice, uk clinical trials

Primary Trial ID Number

NCT01925625

 

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.
Research Details
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.
Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Study Type
Interventional
Intervention
Biological : Early CDT Lung blood test
Study Arm Groups : Early CDT Lung Test

Intervention Type
See Interventions above
Primary Outcome Measures
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
Result Reports
This is available on the Clinicaltrials.gov website

Gender
Both
Age Range
50 Years – 75 Years
Who Can Participate
Sorry, this information is not available
Number of Participants
10000
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above

Trial Location(s)
Research Site
Dundee
DD1 9SY
Glasgow
Scotland
Trial Contact(s)
Primary Trial Contact
Frank Sullivan, MbChB
frank.sullivan@nygh.on.ca
0014167566340
Other Trial Contacts
Stuart Schembri, MbChB
s.schembri@dundee.ac.uk
01382 232587
Countries Recruiting
United Kingdom

Scientific Title
Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test
EudraCT Number
Not available for this trial

Other Study ID Numbers
2013ON07
Sponsor(s)
Cheryl Hume

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=19859 →