- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02747355
Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- adrenal carcinoma
- adrenal adenoma
- normal adrenal tissue
Exclusion Criteria:
- NA
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
MCM3 expression
Tidsram: 1 year
|
Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
MCM2 expression
Tidsram: 1 year
|
Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
P53 expression
Tidsram: 1 year
|
Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
NEUROPILIN -1 expression
Tidsram: 1 year
|
Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
METALLOTHIONEIN expression
Tidsram: 1 year
|
Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
SEMAPHORIN-3A expression
Tidsram: 1 year
|
Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
E-caderein expression
Tidsram: 1 year
|
Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
KI67
Tidsram: 1 year
|
Difference in Ki67 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
|
1 year
|
|
Prognosis
Tidsram: 1 year
|
Correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BnaiZion
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