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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02747355
Other study ID # BnaiZion
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT00071058 - Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer Phase 2