The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
21. juni 2013 opdateret af: University of Colorado, Denver
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment.
To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment.
The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer.
The number of cells measured in these cancers has been shown to be prognostic.
There is little information on the presence or importance of circulating tumor cells in bladder cancer.
This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
44
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80010
- University of Colorado Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with muscle-invasive or metastatic bladder cancer with plans for cancer treatment.
Beskrivelse
Inclusion Criteria:
- Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present.
- Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy.
- Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study.
- Subject must be 18 years of age or older
- Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study.
- Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments.
- Predicted life expectancy of > 12 weeks.
Exclusion Criteria:
- Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Bladder cancer
Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of therapy
Tidsramme: baseline and then every 2 months
|
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
|
baseline and then every 2 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of baseline CTC
Tidsramme: baseline and then every 2 months
|
Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.
|
baseline and then every 2 months
|
|
Assessing insulin like growth factor
Tidsramme: baseline and then every 2 months
|
Determine the feasibility of assessing insulin like growth factor (IGF) I-R and c-Met by FISH in circulating tumor cells of patients with advanced bladder cancer.
|
baseline and then every 2 months
|
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Correlation between CTC levels and clinical outcome
Tidsramme: baseline and then every 2 months
|
Evaluate for any potential correlation between CTC levels and clinical outcome
|
baseline and then every 2 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Thomas W. Flaig, MD, University of Colorado, Denver
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2008
Primær færdiggørelse (Faktiske)
1. november 2012
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
25. januar 2009
Først indsendt, der opfyldte QC-kriterier
26. januar 2009
Først opslået (Skøn)
27. januar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08-0018.cc
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 .