Malignant Pleural MesotheliomasVITMPMNCT02603315
Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM)
An observational study of Malignant Pleural Mesotheliomas, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to To assess the correlation between the predictive factor of vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate, and overall survival) . Read more about this study
- Who is it for?
- Ages 39 to 84 years
- Conditions the study is for
- Malignant Pleural Mesotheliomas
- What is being tested?
- marker CD74 and vascular endothelial growth factor VEGF
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to May 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 39 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian patients with confirmed malignant pleural mesothelioma
Who may be able to join
- Histopathological confirmation of malignant pleural mesothelioma .
- Full clinical data.
- Availability for follow up: Personal communication will be attempted in order to collect missing information.
- 3-The files of all patients will be reviewed to analyze the following :
- Operative data if done .
- Pathological review and immunohistochemistry.
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- Laboratory investigations: (routine investigations: complete blood picture,liver and renal function test)
- Radiological investigations:( CXR and CT-chest, Abdominal and pelvic U\S and MRI ).
- Treatment protocols applied: Radiotherapy and Chemotherapy.
- Response and survival after treatment .
Who cannot join
- cases not receive chemotherapy ,on available of evaluation after treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Correlation Between the Predictive Factor of Vascularity (CD74) in Malignant Pleural Mesothelioma and Treatment Results (Response Rate, and Overall Survival )
The purpose of this study is to To assess the correlation between the predictive factor of vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate, and overall survival) .
Read the detailed description
This is a randomized controlled retrospective study through Examination of paraffin blocks of the patient selected to be included in the study for assessment of the selected vascularity marker of malignant pleural mesothelioma of both types . The CD74 (LN2) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed paraffin-embedded tissue sections using Immunohistochemistry test methods.
- Conditions
- Malignant Pleural Mesotheliomas
- Being tested
- marker CD74 and vascular endothelial growth factor VEGF
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marker CD74 and vascular endothelial growth factor VEGFOther
correlate the result of vascularity test done on paraffin blocks on both types of malignant pleural mesothelioma patients diagnosed and receive treatment and evaluated after treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
to correlate the results of the vascularity marker of pleural mesothelioma CD74 of patients attended to Ain Shams University hospitals with the result response of treatment by chemotherapy ,overall survival and progreeion free survival
The cases diagnosed and receive at the least 2-3 cycles of chemotherapy and evaluated after treatment
Measured: 3-4 months
Secondary outcomes (1)
assessment of vascular enothelial growth factor (VEGF) in patient with malignant pleural mesothelioma who attended to Ain Shams University and made comparison with the result of CD 74
The cases diagnosed and receive at the least 2-3 cycles of chemotherapy and evaluated after treatment
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomasStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muna Sami Jassim, Ain Shams University
- Investigators
- Amr S Saad, MD, Study director, Ain Shams UniversityMahmoud Ellithy, MD, Study chair, Ain Shams UniversityDoaa Atef, MD, Study director, Ain Shams UniversityHoda Abougabal, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603315
- Sponsor's protocol ID
- DR-81
- Acronym
- VITMPM
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Correlation Between the Predictive Factor of Vascularity (CD74) in Malignant Pleural Mesothelioma and Treatment Results (Response Rate, and Overall Survival )
- ClinicalTrials.gov ID
- NCT02603315
- Acronym / sponsor ID
- VITMPM / DR-81
- Conditions
- Malignant Pleural Mesotheliomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Nov 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.
The purpose of this study is to To assess the correlation between the predictive factor of vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate, and overall survival) .
Detailed description
This is a randomized controlled retrospective study through Examination of paraffin blocks of the patient selected to be included in the study for assessment of the selected vascularity marker of malignant pleural mesothelioma of both types . The CD74 (LN2) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed paraffin-embedded tissue sections using Immunohistochemistry test methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 39 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients with confirmed malignant pleural mesothelioma
Key inclusion criteria (10 listed)
- Histopathological confirmation of malignant pleural mesothelioma .
- Full clinical data.
- Availability for follow up: Personal communication will be attempted in order to collect missing information.
- Operative data if done .
- Pathological review and immunohistochemistry.
Key exclusion criteria (1 listed)
- cases not receive chemotherapy ,on available of evaluation after treatment
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 |
|---|---|---|
| marker CD74 and vascular endothelial growth factor VEGFcorrelate the result of vascularity test done on paraffin blocks on both types of malignant pleural mesothelioma patients diagnosed and receive treatment and evaluated after treatment | Other | – |
Primary outcome
to correlate the results of the vascularity marker of pleural mesothelioma CD74 of patients attended to Ain Shams University hospitals with the result response of treatment by chemotherapy ,overall survival and progreeion free survival
Time frame: 3-4 months
The cases diagnosed and receive at the least 2-3 cycles of chemotherapy and evaluated after treatment
1 secondary outcome
assessment of vascular enothelial growth factor (VEGF) in patient with malignant pleural mesothelioma who attended to Ain Shams University and made comparison with the result of CD 74
Time frame: 3-4 months
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 1 Jun 2016.
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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.
Amr S Saad, MD study director
Ain Shams University
Mahmoud Ellithy, MD study chair
Ain Shams University
Doaa Atef, MD study director
Ain Shams 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 Malignant Pleural Mesotheliomas, run by Ain Shams University 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 10 inclusion and 1 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 1 Jun 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?
to correlate the results of the vascularity marker of pleural mesothelioma CD74 of patients attended to Ain Shams University hospitals with the result response of treatment by chemotherapy ,overall survival and progreeion free survival (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2016.