Lung CancerNCT02758678
Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients
An observational study of Lung Cancer, run by Science and Technology Park, Center of Innovation Technologies for Human Health at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- A single 2 ml heparinised peripheral blood sample
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: both female and male participants are being studied with confirmed lung cancer
Who may be able to join
- confirmed lung cancer
- WHO 0-2
- 6 month after chemotherapy in palliative patients
Who cannot join
- double cancer
- another cancer
- chemotherapy in radical patients
- prior external beam radiation in an interview with the patient
Trial locations and contacts
1 site in 1 country.
Poland1 site
Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.
Zielona Góra, Lubusz Voivodeship, 65-417
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- A single 2 ml heparinised peripheral blood sample
- Keywords
- P-selectin, Lung Cancer, Raman Spectroscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single 2 ml heparinised peripheral blood sampleBiological
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Biological: A single 2 ml heparinised peripheral blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and Technology Park, Center of Innovation Technologies for Human Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University in Zielona Góra
- Responsible party
- Principal investigator, Edyta Wolny-Rokicka MD.PhD, Science and Technology Park, Center of Innovation Technologies for Human Health
- Investigators
- Edyta I Wolny-Rokicka, MD.PhD, Study chair, Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758678
- Sponsor's protocol ID
- Science and Technology Park,
- Other IDs
- 2/07/2015
- Status last verified
- Oct 2016
- First submitted
- 18 Apr 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 2016 - as a manuscript
Publications
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.
PubMed 9050769Bendas 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.
PubMed 22505933
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of P-selectin Expression on Platelets of Blood Between Serum Samples From Lung Cancer and Healthy Individuals by Using Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT02758678
- Acronym / sponsor ID
- Science and Technology Park,
- Conditions
- Lung Cancer
- Keywords
- P-selectin, Lung Cancer, Raman Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Science and Technology Park, Center of Innovation Technologies for Human HealthIndustry (pharma, biotech, devices)
- Collaborators
- University in Zielona Góra
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-patients with operating tumor | – | Biological: A single 2 ml heparinised peripheral blood sample1- 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. |
| 2-patients with advanced desease. | – | Biological: A single 2 ml heparinised peripheral blood sample2- 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 |
| 3-patients with inoperable disease | – | Biological: A single 2 ml heparinised peripheral blood sampleIn 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- both female and male participants are being studied with confirmed lung cancer
Key inclusion criteria (3 listed)
- confirmed lung cancer
- WHO 0-2
- 6 month after chemotherapy in palliative patients
Key exclusion criteria (4 listed)
- double cancer
- another cancer
- chemotherapy in radical patients
- prior external beam radiation in an interview with the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A single 2 ml heparinised peripheral blood sampleA single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis: | Biological | 1-patients with operating tumor, 2-patients with advanced desease., 3-patients with inoperable disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Background: PubMed 9050769Blann 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.
- Background: PubMed 22505933Bendas 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.
- Individual participant dataSharing planned: Yes. 2016 - as a manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edyta I Wolny-Rokicka, MD.PhD study chair
Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Science and Technology Park, Center of Innovation Technologies for Human Health at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758678, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.