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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

Tracking Information
First Submitted Date May 2, 2016
First Posted Date May 4, 2016
Last Update Posted Date February 23, 2018
Estimated Study Start Date July 30, 2019
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2017)
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.
Original Primary Outcome Measures
 (submitted: May 3, 2016)
CD 74 and VEGF detection effect on response to treatment [ Time Frame: Essay done before starting treatment and correlated with the response ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma
Official Title Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Receiving Pemetrexed/Platinum Protocol
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Paraffin Blocks
Sampling Method Probability Sample
Study Population Patients suffering from Malignant Pleural Mesothelioma
Condition Malignant Pleural Mesothelioma
Intervention 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.

Study Groups/Cohorts CD74 - VEGF arm
Intervention: Other: CD 74, VEGF detection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 3, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2021
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02761863
Other Study ID Numbers CURE001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ahmed Nagy, Ain Shams University
Study Sponsor Ain Shams University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams University
Verification Date February 2018