- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02747355
Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Forventet)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- adrenal carcinoma
- adrenal adenoma
- normal adrenal tissue
Exclusion Criteria:
- NA
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BnaiZion
Plan for individuelle deltakerdata (IPD)
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