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

NCT ID: NCT02761863

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2021-07-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

CD74 - VEGF arm

CD 74, VEGF detection

Intervention Type: 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.

Interventions

CD 74, VEGF detection

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma

2. No prior chemotherapy.

3. ECOG less than or equal to 2 .

4. Measurable disease according to the requirements of SWOG criteria.

5. Age ≥ 19 years .

6. Estimated life expectancy of at least 12 weeks .

7. 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).

Exclusion Criteria

1. Presence of central nervous system metastases.

2. 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).

3. Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min).

4. Serious concomitant systemic disorder incompatible with the study.

5. 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).

6. Pregnancy

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Nagy

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CURE001

Identifier Type: -

Identifier Source: org_study_id