Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

• Conditions: Adrenal Cortex Neoplasms; Adrenal Cortex Diseases

• Registration Number: NCT02747355
• Lead Sponsor: Bnai Zion Medical Center

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 Description

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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Study Start: 2016-08-18
• Primary Completion: 2018-07-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• adrenal carcinoma
• adrenal adenoma
• normal adrenal tissue

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
P53 expression	1 year	Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
E-caderein expression	1 year	Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
MCM2 expression	1 year	Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
METALLOTHIONEIN expression	1 year	Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
MCM3 expression	1 year	Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
NEUROPILIN -1 expression	1 year	Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
SEMAPHORIN-3A expression	1 year	Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

Secondary Outcome Measures

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