Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients

October 17, 2016 updated by: Edyta Wolny-Rokicka MD.PhD, Science and Technology Park, Center of Innovation Technologies for Human Health

Analysis of P-selectin Expression on Platelets of Blood Between Serum Samples From Lung Cancer and Healthy Individuals by Using Raman Spectroscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lubuskie
      • Zielona Góra, Lubuskie, Poland, 65-417
        • Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

both female and male participants are being studied with confirmed lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1-patients with operating tumor

1- 23 patients with operating tumor; In 1 group the specimens of blood will be collected day before surgery and 1-2 month after surgery. Will be collected: histopathology outcomes - type carcinoma, tumore volume and before surgery: morphology and coagulation system. Will be assessed correlation between mentioned above factors and concentration of P-selectin.

Will be compared concentration of P-selectin in 3 groups of patients.

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.
Biological: A single 2 ml heparinised peripheral blood sample
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:
2-patients with advanced desease.

2- ten patients with advanced and metastatic disease who received palliative RT (RT - radiotherapy);

In 2 group - the specimens of blood we collected before palliative treatment-radiotherapy. Will be collected: histopathology outcomes - type carcinoma, morphology. Will be assessed correlation between mentioned factors and concentration of P-selectin. Will be compared concentration of P-selectin in 3 groups of patients. Serum separation and Raman spectroscopy analysis:

A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens.The Raman spectra (RS) assessed as above
Biological: A single 2 ml heparinised peripheral blood sample
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:
3-patients with inoperable disease

In group 3 - the specimens of blood we collected before radical treatment and one month after completion treatment. Will be collected: histopathology outcomes - type carcinoma, morphology. Will be assessed correlation between mentioned above factors and concentration of P-selectin. Will be compared concentration of P-selectin in 3 groups of patients. 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.
Biological: A single 2 ml heparinised peripheral blood sample
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compared to the healthy participants.
Time Frame: 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.
Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compare the concentration of P-selectin depends on tumor volume.Comparison between 3 groups and in the end, compared to the healthy population
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Science and Technology Park, Center of Innovation Technologies for Human Health

Collaborators

University in Zielona Góra

Investigators

  • Study Chair: Edyta I Wolny-Rokicka, MD.PhD, Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Science and Technology Park,
  • 2/07/2015 (Registry Identifier: bioethical commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

2016 - as a manuscript

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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