- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02747355
Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- adrenal carcinoma
- adrenal adenoma
- normal adrenal tissue
Exclusion Criteria:
- NA
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
MCM3 expression
Tidsramme: 1 year
|
Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
MCM2 expression
Tidsramme: 1 year
|
Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
P53 expression
Tidsramme: 1 year
|
Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
NEUROPILIN -1 expression
Tidsramme: 1 year
|
Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
METALLOTHIONEIN expression
Tidsramme: 1 year
|
Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
SEMAPHORIN-3A expression
Tidsramme: 1 year
|
Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
E-caderein expression
Tidsramme: 1 year
|
Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
KI67
Tidsramme: 1 year
|
Difference in Ki67 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
Prognosis
Tidsramme: 1 year
|
Correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BnaiZion
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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