Non-small Cell Lung CancerNCT02445924
Micro RNA Genetic Signature in NSCLC Egyptian Patients
An observational study of Non-small Cell Lung Cancer, run by Adel Salah Bediwy at 1 site in Egypt.
Trial summary
This study will be carried out on 40 subjects at Chest department Tanta university hospital The subjects will be classified into three groups: Group I: will include ten non smoker volunteers (control group I). GroupII: will include ten smoker volunteers (control groupII). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Aug 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be carried out on 40 subjects at Chest department Tanta university hospital. The subjects will be classified into three groups: * Group I: will include ten non smoker volunteers (control group I). * GroupII: will include ten smoker volunteers (control groupII). * Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.
Who may be able to join
- Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.
- -
Who cannot join
- Diagnosis of asthma or COPD.
- Broncheiactasis.
- upper/lower respiratory tract infection in the preceding 4 weeks.
- Active pulmonary tuberculosis.
- Associated cancer beside lung cancer.
- Patients who received chemotherapy, surgery or radiation therapy previous to the sample collection.
Show all 11Show fewer
- Diagnosis of asthma or COPD.
- Broncheiactasis.
- Upper/lower respiratory tract infection in the preceding 4 weeks.
- Active pulmonary tuberculosis
- Smoking in group I.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Department, Faculty of Medicine, Tanta University
Tanta, Gharbia Governorate, 31111
About this study
Official title: Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients
This study will be carried out on 40 subjects at Chest department Tanta university hospital
The subjects will be classified into three groups:
- Group I: will include ten non smoker volunteers (control group I).
- GroupII: will include ten smoker volunteers (control groupII).
- Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.
Read the detailed description
The patients and control groups will be subjected to the following:
- Complete history taking and complete general examination.
- Complete chest examination.
- Radiological assessment including chest x ray (posteroanterior and lateral view).
- Computed tomography (CT) chest for all patients in group III and when needed in group I and II.
- Laboratory investigations:
- Complete blood picture
- Fasting and post parandial blood sugar level
- liver function tests
- kidney function tests (urea and creatinine).
- Prothrombine time and activity.
- Zeil-Neelsen staining of sputum.
- Tumour markers including α Fetoprotein, Carcino Embryonic antigen (CEA), CA19-9, CA 125, CA15-3 and others.
- Venous blood samples will be collected from peripheral blood (5 ml) under complete aseptic technique. Serum samples will be obtained by centrifugation. Isolation of total RNA from serum pools will be performed. RNA profiles and quantification will be assessed using Microarray.
- Lung biopsy either transbronchial via bronchoscopy or peripherally via ultrasound , CT guided, thoracoscopy or open lung biopsy will be performed with isolation of total RNA from lung tissue biopsy. RNA profiles and quantification will be assessed using Microarray.
- Bronchoalveolar lavage will be performed with isolation of total RNA from it. RNA profiles will be assessed using Microarray.
Ethical considerations:
- Informed consent will be taken from all subject's and include:
- The aim of research. B. All data are confidential. C. All data will be used in research only.
- For patient's privacy:
- There will be a code number for each patient in special folder. B. The results of research will be used in scientific publishing only.
- Unexpected risks that appear during the courses of research will be cleared to the participants and the ethical committee on time.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- genetic signature, non-small cell lung cancer, micro RNA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 | ten non smoker volunteers | |
| Control group 2 | ten smoker volunteers | |
| NSCLC patients | twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adel Salah Bediwy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adel Salah Bediwy, Tanta University
- Investigators
- Amgad A Farahat, MD, Study chair, Chest Department, Faculty of Medicine, Tanta UniversityAyman H Abd El-Zaher, MD, Principal investigator, Chest Department, Faculty of Medicine, Tanta UniversitySaid M Hammad, MD, Principal investigator, Clinical Pathology Department, Faculty of Medicine, Tanta UniversityAdel S Bediwy, MD, Principal investigator, Chest Department, Faculty of Medicine, Tanta UniversityAyman A Al Saka, MD, Principal investigator, Pathology Department, Faculty of Medicine, Tanta UniversitySamar A Mansour, Master, Principal investigator, Chest Department, Faculty of Medicine, Tanta UniversityAbdel-Aziz A Zidan, PHD, Principal investigator, Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445924
- Sponsor's protocol ID
- 2858/11/14
- Status last verified
- Oct 2016
- First submitted
- 13 May 2015
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang D, Shen Y, Wang M, Yang R, Wang Z, Sui A, Jiao W, Wang Y. Identification of plasma microRNAs as novel noninvasive biomarkers for early detection of lung cancer. Eur J Cancer Prev. 2013 Nov;22(6):540-8. doi: 10.1097/CEJ.0b013e32835f3be9.
PubMed 23462458Keller A, Leidinger P, Borries A, Wendschlag A, Wucherpfennig F, Scheffler M, Huwer H, Lenhof HP, Meese E. miRNAs in lung cancer - studying complex fingerprints in patient's blood cells by microarray experiments. BMC Cancer. 2009 Oct 6;9:353. doi: 10.1186/1471-2407-9-353.
PubMed 19807914Leidinger P, Keller A, Meese E. MicroRNAs - Important Molecules in Lung Cancer Research. Front Genet. 2012 Jan 23;2:104. doi: 10.3389/fgene.2011.00104. eCollection 2011.
PubMed 22303398
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro RNA Genetic Signature in Non-small Cell Lung Cancer Egyptian Patients
- ClinicalTrials.gov ID
- NCT02445924
- Acronym / sponsor ID
- 2858/11/14
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- genetic signature, non-small cell lung cancer, micro RNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Adel Salah BediwyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 May 2015 (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.
This study will be carried out on 40 subjects at Chest department Tanta university hospital
The subjects will be classified into three groups:
- Group I: will include ten non smoker volunteers (control group I).
- GroupII: will include ten smoker volunteers (control groupII).
- Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.
Detailed description
The patients and control groups will be subjected to the following:
- Complete history taking and complete general examination.
- Complete chest examination.
- Radiological assessment including chest x ray (posteroanterior and lateral view).
- Computed tomography (CT) chest for all patients in group III and when needed in group I and II.
- Laboratory investigations:
- Complete blood picture
- Fasting and post parandial blood sugar level
- liver function tests
- kidney function tests (urea and creatinine).
- Prothrombine time and activity.
- Zeil-Neelsen staining of sputum.
- Tumour markers including α Fetoprotein, Carcino Embryonic antigen (CEA), CA19-9, CA 125, CA15-3 and others.
- Venous blood samples will be collected from peripheral blood (5 ml) under complete aseptic technique. Serum samples will be obtained by centrifugation. Isolation of total RNA from serum pools will be performed. RNA profiles and quantification will be assessed using Microarray.
- Lung biopsy either transbronchial via bronchoscopy or peripherally via ultrasound , CT guided, thoracoscopy or open lung biopsy will be performed with isolation of total RNA from lung tissue biopsy. RNA profiles and quantification will be assessed using Microarray.
- Bronchoalveolar lavage will be performed with isolation of total RNA from it. RNA profiles will be assessed using Microarray.
Ethical considerations:
- Informed consent will be taken from all subject's and include:
- The aim of research. B. All data are confidential. C. All data will be used in research only.
- For patient's privacy:
- There will be a code number for each patient in special folder. B. The results of research will be used in scientific publishing only.
- Unexpected risks that appear during the courses of research will be cleared to the participants and the ethical committee on time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | – | –ten non smoker volunteers |
| Control group 2 | – | –ten smoker volunteers |
| NSCLC patients | – | –twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be carried out on 40 subjects at Chest department Tanta university hospital. The subjects will be classified into three groups: * Group I: will include ten non smoker volunteers (control group I). * GroupII: will include ten smoker volunteers (control groupII). * Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.
Key inclusion criteria (2 listed)
- Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.
- -
Key exclusion criteria (11 listed)
- Diagnosis of asthma or COPD.
- Broncheiactasis.
- upper/lower respiratory tract infection in the preceding 4 weeks.
- Active pulmonary tuberculosis.
- Associated cancer beside lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray
Time frame: one year
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 24 Oct 2016.
- Background: PubMed 23462458Tang D, Shen Y, Wang M, Yang R, Wang Z, Sui A, Jiao W, Wang Y. Identification of plasma microRNAs as novel noninvasive biomarkers for early detection of lung cancer. Eur J Cancer Prev. 2013 Nov;22(6):540-8. doi: 10.1097/CEJ.0b013e32835f3be9.
- Background: PubMed 19807914Keller A, Leidinger P, Borries A, Wendschlag A, Wucherpfennig F, Scheffler M, Huwer H, Lenhof HP, Meese E. miRNAs in lung cancer - studying complex fingerprints in patient's blood cells by microarray experiments. BMC Cancer. 2009 Oct 6;9:353. doi: 10.1186/1471-2407-9-353.
- Background: PubMed 22303398Leidinger P, Keller A, Meese E. MicroRNAs - Important Molecules in Lung Cancer Research. Front Genet. 2012 Jan 23;2:104. doi: 10.3389/fgene.2011.00104. eCollection 2011.
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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.
Amgad A Farahat, MD study chair
Chest Department, Faculty of Medicine, Tanta University
Ayman H Abd El-Zaher, MD principal investigator
Chest Department, Faculty of Medicine, Tanta University
Said M Hammad, MD principal investigator
Clinical Pathology Department, Faculty of Medicine, Tanta University
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 Non-small Cell Lung Cancer, run by Adel Salah Bediwy at 1 site in Egypt.
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 2 inclusion and 11 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 24 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 Egypt. 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?
Detect micro RNA genetic signature pattern in non-small cell lung cancer Egyptian patients assessed using Microarray (time frame: one 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 NCT02445924, which also lists 3 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 24 Oct 2016.