CClinicalTrials.gg
Status unknownNCT02761863Updated Feb 23, 2018

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

An observational study in Malignant Pleural Mesothelioma, sponsored by Ain Shams University. Status unknown. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
19 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Malignant Pleural Mesothelioma

Keywords

  • Mesothelioma
  • CD 74
  • VEGF
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In context

Mesothelioma

470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 64 observational studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients suffering from Malignant Pleural Mesothelioma

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

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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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • CD74 - VEGF arm

    Other: CD 74, VEGF detection

Interventions

  • OtherCD 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.

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What researchers measure

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.

    Time frame: Essay done before starting treatment and correlated with the response

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02761863
Lead sponsor
Ain Shams University
Responsible party
Ahmed Nagy (Dr, Ain Shams University) — Principal investigator
First posted
May 4, 2016
Start date
Jul 30, 2019 (estimated)
Primary completion
Jan 30, 2020 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Feb 23, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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