Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer (PORCH)
PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary purpose of this protocol is to create a registry of elderly patients with high-risk invasive bladder cancer undergoing radical cystectomy with or without preoperative chemotherapy.
Secondary objectives will include an exploration of the association between functional status, surgical complications, and laboratory markers with complications and survival. In addition, exploratory analyses may evaluate the association of expression of the senescence marker p16INK4a and the morbidity and mortality associated with treatment.
Patients will be asked to complete a Geriatric Assessment (GA) and FACT-Bl serially over the course of the study in order to evaluate their functional status and quality of life during the course of treatment. Additionally, complications will be tracked in an inpatient and outpatient setting using the Memorial Sloan Kettering Cancer Center (MSKCC) complications grading system.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- UNC Lineberger Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment.
- Signed, IRB approved written informed consent.
- Completion of baseline Geriatric Assessment
Exclusion Criteria:
- Inability to read and speak English
- Inability to comply with study for any other reason than language
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Bladder Cancer Patients
Patients diagnoses with bladder cancer who are eligible to undergo treatment.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To collect the number of changes in functional status, surgical complications and survival status collected in a prospective database of patients undergoing a radical cystectomy with or without chemotherapy
Tidsramme: 1 Year
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To collect the number of changes in functional status, surgical complications, and survival in patients with urothelial carcinoma of the bladder following radical cystectomy with or without neoadjuvant chemotherapy in a prospective database (to be called the PORCH database- "Prospective Outcomes of Radical cystectomy with or without Chemotherapy").
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1 Year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To measure associations between baseline measures with post-surgery and 90 day outcome measures
Tidsramme: 2 years
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Measure the association of all baseline measures with the outcomes of complications post-surgery and 90 day mortality for the 25 patients entered into the database who complete the GA and FACT-Bl questionnaires.
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2 years
|
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To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics.
Tidsramme: 2 years
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2 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Angela Smith, MD, University of North Carolina Lineberger Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LCCC1206
- 12-0577 (Anden identifikator: UNC IRB)
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