A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery.
Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, États-Unis, 10065
- New York Presbyterian Hospital-Weill Medical College of Cornell University
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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 in whom pelvic lymph node dissection can be performed;
- Any male and/or female, who is ≥18 years of age;
- Pathological diagnosis of urothelial carcinoma of the bladder;
- Localized muscle-invasive disease defined as clinical stage T2-4aN0M0 tumors;
- Did not receive neoadjuvant therapy;
- No radiographic evidence of metastatic disease on CT scans of the abdomen and pelvis, chest x-ray, or bone scan;
- Informed consent before study participation
Exclusion Criteria:
- Prior systemic chemotherapy;
- Prior radiation therapy;
- A history of another ongoing malignancy within the past 5 years other than basal cell carcinoma of the skin
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Blood sample
the blood sample only collected prior to surgery
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The research intervention is the blood sample only collected prior to surgery.
Analyses of the data will be made by correlating the gene profile expression with the pathologic finding at surgery and the clinical status of the patients 2 years after surgery.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Assess the ability of a mononuclear-cell gene signature to predict the presence of metastatic cancer in the regional L.N. of patients with muscle-invasive bladder cancer at the time of cystectomy with PLND for presumed localized muscle-invasive disease.
Délai: 2 years
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Assess the ability of a mononuclear-cell gene signature, alone or in combination with pathological staging, to predict any metastatic disease w/i 2 yrs of cystectomy with PLND in pts. with clinical organ-confined muscle-invasive bladder cancer staging.
Délai: 2 years
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2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guido Dalbagni, MD, Memorial Sloan Kettering Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 09-054
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