Plain English Summary
Background and study aims
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It usually grows and spreads more slowly than small cell lung cancer. Non-invasive (harmless) yet reliable tests are needed to tell NSCLC apart from other lung diseases that have similar symptoms. Carbohydrate sulfotransferase 7 (CHST7) is a substance that is involved in the development of several different cancers including NSCLC. The aim of this study is find out whether the levels of CHST7 in the blood can be used to tell apart NSCLC from other lung diseases with similar symptoms.
Who can participate?
Patients age over 18 with suspected lung cancer
What does the study involve?
During the routine diagnostic tests for suspected lung cancer, the participants’ CHST7 levels are measured along with other blood substances, including routinely used tumor markers. The results are analysed to work out whether CHST7 levels can be used as a way to diagnose NSCLC.
What are the possible benefits and risks of participating?
There are no direct benefits of participation. Participants must provide a routine blood sample; there are no additional risks.
Where is the study run from?
1. Osijek University Hospital (Croatia)
2. Clinical Hospital Center Zagreb (Croatia)
When is the study starting and how long is it expected to run for?
July 2012 to December 2015
Who is funding the study?
1. Osijek University Hospital (Croatia)
2. Našice General Hospital (Croatia)
Who is the main contact?
Dr Zeljko Debeljak
Trial website
Contact information
Type
Public
Primary contact
Dr Zeljko Debeljak
ORCID ID
http://orcid.org/0000-0002-1789-5387
Contact details
J. Huttlera 4
Osijek
31 000
Croatia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Carbohydrate sulfotransferase 7 in non-small cell lung carcinoma: a clinical pilot diagnostic accuracy study of the biomarker candidate
Acronym
Study hypothesis
Serum carbohydrate sulfotransferase 7 (CHST7) concentration may improve the non-invasive differentiation of non-small cell lung carcinoma (NSCLC) from the pulmonary diseases presenting with similar clinical manifestations including non-malignant inflammations and other malignancies.
Ethics approval
1. Ethics Committee of Osijek University Hospital, 15/12/2011
2. Ethics Committee of Clinical Hospital Center Zagreb, 04/07/2012
Study design
Two-center case-control diagnostic accuracy study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Non-small cell lung carcinoma
Intervention
Patients are recruited consecutively during the routine diagnostic work up for suspected lung carcinoma. CHST7 concentration is determined along with other serum parameters, including routinely used tumor markers. Its diagnostic performance as a NSCLC biomarker candidate is evaluated during a period of two and a half years.
The CHST7 values of each participant are compared with the appropriate cut off values (index test). According to the comparison participants are classified either to the NSCLC group or to the control group. These classification results are compared with the 'gold standard' i.e. histological or cytological diagnosis (reference standard test).
Intervention type
Other
Phase
Drug names
Primary outcome measure
The diagnostic utility of CHST7 in NSCLC, evaluated using area under the curve (AUC) and other statistical measures coming from receiver-operation-characteristic analysis
Secondary outcome measures
Evaluation of multivariate performance conducted using crossvalidation accuracy
Overall trial start date
01/07/2012
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Suspected pulmonary malignant disease accompanied with clinical and laboratory signs of inflammation
3. Therapy-naïve
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Participant refused to participate
2. Insufficient or unavailable diagnostic information
Recruitment start date
04/07/2012
Recruitment end date
30/04/2015
Locations
Countries of recruitment
Croatia
Trial participating centre
Osijek University Hospital
Osijek
31 000
Croatia
Trial participating centre
Clinical Hospital Center Zagreb
Zagreb
10 000
Croatia
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Osijek
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Našice General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be disseminated in a form of scientific publication by the end of 2017.
IPD sharing plan
The datasets generated and/or analysed during the current study are available from Zeljko Debeljak on reasonable request
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29648993