Pilot study of carbohydrate sulfotransferase 7 diagnostic utility in non-small cell lung carcinoma

ISRCTN ISRCTN16181999
DOI https://doi.org/10.1186/ISRCTN16181999
Secondary identifying numbers N/A
Submission date
28/09/2016
Registration date
17/10/2016
Last edited
10/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Zeljko Debeljak
Public

J. Huttlera 4
Osijek
31 000
Croatia

ORCiD logoORCID ID 0000-0002-1789-5387

Study information

Study designTwo-center case-control diagnostic accuracy study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleCarbohydrate sulfotransferase 7 in non-small cell lung carcinoma: a clinical pilot diagnostic accuracy study of the biomarker candidate
Study objectivesSerum 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(s)1. Ethics Committee of Osijek University Hospital, 15/12/2011
2. Ethics Committee of Clinical Hospital Center Zagreb, 04/07/2012
Health condition(s) or problem(s) studiedNon-small cell lung carcinoma
InterventionPatients 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 typeOther
Primary outcome measureThe 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 measuresEvaluation of multivariate performance conducted using crossvalidation accuracy
Overall study start date01/07/2012
Completion date31/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants150
Key inclusion criteria1. Age > 18 years
2. Suspected pulmonary malignant disease accompanied with clinical and laboratory signs of inflammation
3. Therapy-naïve
Key exclusion criteria1. Participant refused to participate
2. Insufficient or unavailable diagnostic information
Date of first enrolment04/07/2012
Date of final enrolment30/04/2015

Locations

Countries of recruitment

  • Croatia

Study participating centres

Osijek University Hospital
Osijek
31 000
Croatia
Clinical Hospital Center Zagreb
Zagreb
10 000
Croatia

Sponsor information

Osijek University Hospital
Hospital/treatment centre

J. Huttlera 4
Osijek
31 000
Croatia

Funders

Funder type

Hospital/treatment centre

University Hospital Osijek

No information available

Našice General Hospital

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults will be disseminated in a form of scientific publication by the end of 2017.
IPD sharing planThe datasets generated and/or analysed during the current study are available from Zeljko Debeljak on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/07/2018 Yes No

Editorial Notes

10/07/2018: Publication reference added.