Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background:
When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material&Method:
All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:
- Preoperative MRI and targeted biopsies + random biopsies .
- Random biopsies (gold standard).
Only patients with a positive MRI were included in this collateral study.
The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Oslo, Norge, 0514
- Oslo University Hospital , Aker
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- No previous prostate biopsies
- Positive MRI
- Signed letter of informed concent
Exclusion Criteria:
- Contraindications to MRI
- Previous prostate biopsies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: MRI and targeted biopsies
All patients receive the same level/number of diagnostic procedures.
They all undergo targeted biopsies which are compared to the cytological imprints.
|
Each targeted biopsy is subject to cytological imprints.
It causes no extra biopsies or extra discomfort for the patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
Tidsramme: 15 months
|
The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard).
Measure of agreement, sensitivity and specificity will be calculated.
|
15 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interobserver variability
Tidsramme: 15 months
|
The cytological imprints will be evaluated by three different cytologists and classified as either negative or positive.
The results will be compared to the histology which defines the gold standard.
Any difference in evaluation will be assessed.
|
15 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The detection rate of high grade cancer
Tidsramme: 15 months
|
The cytology will be compared to the specific Gleason score in patients with positive histology in order to evaluate any difference in the detection rate of intermediate/high grade cancer (Gleason score 7 or higher) and low grade cancer (<Gleason score 6).
|
15 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Eduard Baco, MD, Oslo University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OsloUH_2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .