Clinical trial NCT02758678: Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients
Official title: Analysis of P-selectin Expression on Platelets of Blood Between Serum Samples From Lung Cancer and Healthy Individuals by Using Raman Spectroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: P-selectin
Lung Cancer
Raman Spectroscopy
Lead sponsor: Science and Technology Park, Center of Innovation Technologies for Human Health
Sponsor class: INDUSTRY
Collaborators: name: University in Zielona Góra
First posted: 2016-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: both female and male participants are being studied with confirmed lung cancer

Brief summary: Purpose:

Selectins are vascular cell adhesion molecules involved in adhesive interactions of leukocytes and platelets and endothelium within the blood circulation.

Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion molecule and component of the membrane of the platelet alpha granulate has been proposed as a one marker of platelet activation. In this study we evaluate of expression of P selectin on platelets of blood between serum samples from lung cancer and healthy individuals.

Detailed description: Material and Methods:

The investigators enrolled patients with lung cancer which divided on 3 group: 1- 23 patients with operating tumor; 2-ten patients with advanced and metastatic disease who received palliative RT (RT - radiotherapy); 3-five patients with advanced inoperable disease, who received radical RT or RT + CT (CT- chemotherapy).

In 1 group the specimens of blood we collected before surgery and 1-2 month after. In 2 group - before palliative treatment and in group 3 before radical treatment and one month after completion treatment. To compare to serum specimens from patients with lung cancer was obtained plasma from healthy volunteers.

Serum separation and Raman spectroscopy analysis:

A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30 min. The Raman system (Renishaw inVia Microscope integrated with Leica microscope) was calibrated with a silicon standard using the Raman peak at 520 cm-1. Multiple scans were conducted on the solid residue by moving the substrate on an X - Y stage. The wavelength of excitation was 785 nm and the laser beam was focused on the surface of the sample with a 50x objective. The radius on the beam was 3.0 µm and the laser power irradiation over the sample was 5mW. Each spectrum was taken with an exposure of 30s, 10 accumulation and collected in the region from 400 to 1540 cm-1.

Eligibility criteria: Inclusion Criteria:

* confirmed lung cancer
* WHO 0-2
* 6 month after chemotherapy in palliative patients

Exclusion Criteria:

* double cancer
* another cancer
* chemotherapy in radical patients
* prior external beam radiation in an interview with the patient

Primary outcomes:
measure: Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compared to the healthy participants.
timeFrame: The study started from November 2015 and will be completed in May 2016. The end of the study will be July 2016.Data will be presented up to 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Zielona Góra
country: Poland
facility: Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.
state: Lubuskie
Study officials:
affiliation: Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland
name: Edyta I Wolny-Rokicka, MD.PhD
role: STUDY_CHAIR
References:
citation: Blann AD, Lip GY. Hypothesis: is soluble P-selectin a new marker of platelet activation? Atherosclerosis. 1997 Feb 10;128(2):135-8. doi: 10.1016/s0021-9150(96)05980-1. No abstract available.
citation: Bendas G, Borsig L. Cancer cell adhesion and metastasis: selectins, integrins, and the inhibitory potential of heparins. Int J Cell Biol. 2012;2012:676731. doi: 10.1155/2012/676731. Epub 2012 Feb 12.