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

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ClinicalTrials.gov Identifier: NCT02761863
Recruitment Status : Not yet recruiting
First Posted : May 4, 2016
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Nagy, Ain Shams University

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.

Condition or disease Intervention/treatment
Malignant Pleural Mesothelioma Other: CD 74, VEGF detection

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Receiving Pemetrexed/Platinum Protocol
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Group/Cohort Intervention/treatment
CD74 - VEGF arm Other: 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.





Primary Outcome Measures :
  1. CD 74 and VEGF detection effect on response to treatment [ Time Frame: Essay done before starting treatment and correlated with the response ]

    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.



Biospecimen Retention:   Samples Without DNA
Paraffin Blocks


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from Malignant Pleural Mesothelioma
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

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Responsible Party: Ahmed Nagy, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT02761863     History of Changes
Other Study ID Numbers: CURE001
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ahmed Nagy, Ain Shams University:
Mesothelioma
CD 74
VEGF

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial