Clinical trial NCT02747355: Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
Official title: Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Cortex Neoplasms
Adrenal Cortex Diseases
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* adrenal carcinoma
* adrenal adenoma
* normal adrenal tissue

Exclusion Criteria:

* NA

Primary outcomes:
measure: MCM3 expression
timeFrame: 1 year
measure: MCM2 expression
timeFrame: 1 year
measure: P53 expression
timeFrame: 1 year
measure: NEUROPILIN -1 expression
timeFrame: 1 year
measure: METALLOTHIONEIN expression
timeFrame: 1 year
measure: SEMAPHORIN-3A expression
timeFrame: 1 year
measure: E-caderein expression
timeFrame: 1 year
Secondary outcomes:
measure: KI67
timeFrame: 1 year
measure: Prognosis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: