Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

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.

Study Overview

• Status: Unknown
• Conditions: Adrenal Cortex Neoplasms; Adrenal Cortex Diseases

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 Type: Observational
• Enrollment (Anticipated): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adrenal tissue from patients diagnosed with adrenocortical carcinoma, adrenal adenoma and normal adrenals from patients who had renal and adrenal excision for renal cancer

Description

Inclusion Criteria:

• adrenal carcinoma
• adrenal adenoma
• normal adrenal tissue

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenal Cortex Neoplasms
• Other Study ID Numbers: BnaiZion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES