NCT02758678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

April 18, 2016

Last Update Submit

October 17, 2016

Conditions

Keywords

P-selectinLung CancerRaman Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compared to the healthy participants.

    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.

Study Arms (3)

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

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

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

Interventions

A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:

1-patients with operating tumor2-patients with advanced desease.3-patients with inoperable disease

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.

Zielona Góra, Lubusz Voivodeship, 65-417, Poland

Location

Related Publications (2)

  • 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.

    PMID: 9050769BACKGROUND
  • 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.

    PMID: 22505933BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A single 2 ml heparinised peripheral blood sample was centrifuges to get serum

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Edyta I Wolny-Rokicka, MD.PhD

    Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 18, 2016

First Posted

May 2, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

2016 - as a manuscript

Locations