Pilot study of carbohydrate sulfotransferase 7 diagnostic utility in non-small cell lung carcinoma
| ISRCTN | ISRCTN16181999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16181999 |
| Protocol serial number | N/A |
| Sponsor | Osijek University Hospital |
| Funders | University Hospital Osijek, Našice General Hospital |
- 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
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
Public
J. Huttlera 4
Osijek
31 000
Croatia
 ORCID ID |
0000-0002-1789-5387 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Two-center case-control diagnostic accuracy study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Carbohydrate sulfotransferase 7 in non-small cell lung carcinoma: a clinical pilot diagnostic accuracy study of the biomarker candidate |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
The diagnostic utility of CHST7 in NSCLC, evaluated using area under the curve (AUC) and other statistical measures coming from receiver-operation-characteristic analysis |
| Key secondary outcome measure(s) |
Evaluation of multivariate performance conducted using crossvalidation accuracy |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Age > 18 years 2. Suspected pulmonary malignant disease accompanied with clinical and laboratory signs of inflammation 3. Therapy-naïve |
| Key exclusion criteria | 1. Participant refused to participate 2. Insufficient or unavailable diagnostic information |
| Date of first enrolment | 04/07/2012 |
| Date of final enrolment | 30/04/2015 |
Locations
Countries of recruitment
- Croatia
Study participating centres
31 000
Croatia
10 000
Croatia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2018: Publication reference added.
