Clinical Trial: Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

Brief Summary: In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A.

Detailed Summary:

One of the problems in managing adrenocortical tumors is the ability to distinguish between benign and malignant tumors, while needle biopsy is unable to distinguish between the two situations. Therefore, when imaging tests demonstrate a suspected malignant adrenal tumor, surgical excision of the tumor is needed. Usually, the histological WIESS criteria are used in order to determine malignancy. However, there are cases when adrenal tumors were defined by WIESS criteria as benign but metastasized later. Moreover, there is no reliable test than can determine prognosis. KI-67 labeling index is a proliferation biomarker which is used to tell more about the malignant potential and prognosis of adrenal carcinoma.

In various types of tumors, proliferation biomarkers are used in attempt to tell about prognosis. In this study, the investigators will examine whether some biomarkers can differentiate between adrenal carcinoma and adenoma and if the degree of expression of these markers is correlated with prognosis.

The investigators will retrospectively collect 30 cases of adrenal carcinoma, 30 cases of adrenal adenoma and 10 cases of normal adrenals. All specimens are preserved with formalin. The investigators will re-review the WIESS criteria and all samples will be analyzed for the index labeling of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A. The investigators will examine if there is any correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.


Sponsor: Bnai Zion Medical Center

Current Primary Outcome:

  • MCM3 expression [ Time Frame: 1 year ]
    Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • MCM2 expression [ Time Frame: 1 year ]
    Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • P53 expression [ Time Frame: 1 year ]
    Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • NEUROPILIN -1 expression [ Time Frame: 1 year ]
    Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • METALLOTHIONEIN expression [ Time Frame: 1 year ]
    Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • SEMAPHORIN-3A expression [ Time Frame: 1 year ]
    Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • E-caderein expression [ Time Frame: 1 year ]
    Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • KI67 [ Time Frame: 1 year ]
    Difference in Ki67 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
  • Prognosis [ Time Frame: 1 year ]
    Correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.


Original Secondary Outcome: Same as current

Information By: Bnai Zion Medical Center

Dates:
Date Received: April 19, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: April 21, 2016
Last Verified: April 2016