Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer (PORCH)
PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- UNC Lineberger Comprehensive Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Bladder Cancer Patients
Patients diagnoses with bladder cancer who are eligible to undergo treatment.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To measure associations between baseline measures with post-surgery and 90 day outcome measures
Délai: 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.
Délai: 2 years
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2 years
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Angela Smith, MD, University of North Carolina Lineberger Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCCC1206
- 12-0577 (Autre identifiant: UNC IRB)
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