Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

Adrenal Cortex Diseases Clinical Trial

Official title:

Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02747355
• Other study ID #: BnaiZion
• Status: Active, not recruiting
• Start date: August 18, 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adrenal carcinoma

• adrenal adenoma

• normal adrenal tissue

Exclusion Criteria:

Related Conditions & MeSH terms

• Adrenal Cortex Diseases
• Adrenal Cortex Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCM3 expression	Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	MCM2 expression	Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	P53 expression	Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	NEUROPILIN -1 expression	Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	METALLOTHIONEIN expression	Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	SEMAPHORIN-3A expression	Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Primary	E-caderein expression	Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Secondary	KI67	Difference in Ki67 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma	1 year
Secondary	Prognosis	Correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.	1 year