NCT02603315

Brief 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) .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 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

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

October 28, 2015

Last Update Submit

May 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    3-4 months

Interventions

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

Eligibility Criteria

Age39 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian patients with confirmed malignant pleural mesothelioma

You may qualify if:

  • Histopathological confirmation of malignant pleural mesothelioma .
  • Full clinical data.
  • Availability for follow up: Personal communication will be attempted in order to collect missing information.
  • 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 .

You may not qualify if:

  • cases not receive chemotherapy ,on available of evaluation after treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Vascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vascular Endothelial Growth FactorsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Amr S Saad, MD

    Ain Shams University

    STUDY DIRECTOR
  • Mahmoud Ellithy, MD

    Ain Shams University

    STUDY CHAIR
  • Doaa Atef, MD

    Ain Shams University

    STUDY DIRECTOR
  • Hoda Abougabal, MD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in clinical oncology and nuclear medicine department

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 11, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2015-10

Locations