Comparing Outcomes after Cystectomy based on status of molecular markers

Study ID
STU 042011-125

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services

Contact
Cynthia Wynne-Jones
214-645-8793
cindy.wynne-jones@utsouthwestern.edu

Principal Investigator
Yair Lotan

Summary

Every patient who undergoes a cystectomy will have their specimens stained for cell cycle regulators (p53, p21, and p27), Ki-67 and cyclin E1. . Patients with fewer than 3 abnormal markers will be monitored to compare outcomes with patients at high risk. Patients with T3b, T4 or node positive disease will be excluded since they will be considered for chemotherapy outright.
This is an observational study collecting medical record infromation which includes the results of standard of care procedures (physical exam, CT scans, Xrays and blood tests) to monitor and compare outcomes.

Participant Eligibility

1. Status post cystectomy with urinary diversion and bilateral pelvic lymph node dissection for histologically confirmed transitional cell carcinoma.
2. Pathologically confirmed stage pT1-T3a, pN0 (pelvic, internal iliac, external iliac, obturator nodes), M0 (confirmed by clinical preoperative staging with CT chest, abdomen and pelvis and bone scan if indicated by symptoms or increased alkaline phosphatase).

3.. No previous primary malignancy except for carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin.
4.. 18-90 y/o male or female
5. No macroscopic or microscopic residual disease after surgery