Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma

NCT02761863 | Unknown DMC

• 1 other identifier: CURE001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation.

Conditions

Malignant Pleural Mesothelioma

Keywords

Mesothelioma; CD 74; VEGF

Outcome Measures

Primary Outcomes (1)

• CD 74 and VEGF detection effect on response to treatment

  The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation. All MPM samples will be subjected to immunohistochemistry with CD74 and VEGF antibodies. The VEGF will be scored using a 0-3 scoring system to represent the percentage of cytoplasmic positively stained cells in the tumor portion, as follows: 0-10%, 11-30%, 31-60% and 61-100% positive staining correspond to score 0, 1, 2 and 3 respectively. Both CD74 and VEGF immunohistochemical markers will be furtherly categorized in the statistical analyses as none (0)/low (1) vs medium (2)/high expression(3). The CD74 expression will be recorded in the tumor and the stroma semiquantitatively using the histoscore method using four representative fields with the final score resulting from the percentage of tumor cells staining positively multiplied by the staining intensity grade.

  Essay done before starting treatment and correlated with the response

Study Arms (1)

CD74 - VEGF arm

Other: CD 74, VEGF detection

Interventions

CD 74, VEGF detection OTHER

All MPM samples will be subjected to immunohistochemistry with CD74 and VEGF antibodies. The VEGF will be scored using a 0-3 scoring system to represent the percentage of cytoplasmic positively stained cells in the tumor portion, as follows: 0-10%, 11-30%, 31-60% and 61-100% positive staining correspond to score 0, 1, 2 and 3 respectively. Both CD74 and VEGF immunohistochemical markers will be furtherly categorized in the statistical analyses as none (0)/low (1) vs medium (2)/high expression(3). The CD74 expression will be recorded in the tumor and the stroma semiquantitatively using the histoscore method using four representative fields with the final score resulting from the percentage of tumor cells staining positively multiplied by the staining intensity grade.

CD74 - VEGF arm

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from Malignant Pleural Mesothelioma

You may qualify if:

• Histologic or cytologic diagnosis of malignant pleural Mesothelioma
• No prior chemotherapy.
• ECOG less than or equal to 2 .
• Measurable disease according to the requirements of SWOG criteria.
• Age ≥ 19 years .
• Estimated life expectancy of at least 12 weeks .
• Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

You may not qualify if:

• Presence of central nervous system metastases.
• Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
• Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
• Serious concomitant systemic disorder incompatible with the study.
• Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
• Pregnancy

Sponsors & Collaborators

• Ain Shams University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin Blocks

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: July 30, 2019
• Primary Completion: January 30, 2020
• Study Completion: July 30, 2021
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share