- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603315
Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM) (VITMPM)
May 29, 2016 updated by: Muna Sami Jassim, Ain Shams University
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) .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
50
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
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Cairo, Egypt
- Ain Shams University Hospital
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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
39 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Egyptian patients with confirmed malignant pleural mesothelioma
Description
Inclusion Criteria:
- 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.
- 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 .
Exclusion Criteria:
- cases not receive chemotherapy ,on available of evaluation after treatment
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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The cases diagnosed and receive at the least 2-3 cycles of chemotherapy and evaluated after treatment
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3-4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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The cases diagnosed and receive at the least 2-3 cycles of chemotherapy and evaluated after treatment
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3-4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr S Saad, MD, Ain Shams University
- Study Chair: Mahmoud Ellithy, MD, Ain Shams University
- Study Director: Doaa Atef, MD, Ain Shams University
- Study Director: Hoda Abougabal, MD, Ain Shams University
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
October 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 28, 2015
First Submitted That Met QC Criteria
November 10, 2015
First Posted (Estimate)
November 11, 2015
Study Record Updates
Last Update Posted (Estimate)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 29, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Mitosis Modulators
- Growth Substances
- Endothelial Growth Factors
- Mitogens
Other Study ID Numbers
- DR-81
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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