Condition category
Cancer
Date applied
28/09/2016
Date assigned
17/10/2016
Last edited
17/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Osijek University Hospital

Sponsor details

J. Huttlera 4
Osijek
31 000
Croatia

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes