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Cystoscopic Evaluation Before Surgery for Bladder Cancer
N/A
Waitlist Available
Led By Alexander Kutikov, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5years post surgery
Awards & highlights
Study Summary
This trial is testing whether a standardized evaluation of the bladder prior to surgery can predict which patients would benefit from a less invasive surgery.
Who is the study for?
This trial is for adults over 18 with urothelial carcinoma stages T1-T4NanyM0, who are fit enough for surgery (ECOG status 0-3), and have decided on radical cystectomy. They must understand the study and consent to participate. Women of childbearing age should agree to use contraception. Excluded are those with non-curative intent, prior pelvic radiation, or who are pregnant/nursing.Check my eligibility
What is being tested?
The study tests how well a standardized cystoscopic evaluation with tissue sampling before radical cystectomy can predict tumor stage and identify candidates for bladder preservation therapy. It's prospective, meaning it follows patients forward in time from the point of their evaluation through surgery.See study design
What are the potential side effects?
While this trial focuses on diagnostic procedures rather than treatments that typically cause side effects, undergoing radical cystectomy carries risks like bleeding, infection, pain at the surgical site, urinary changes, and potential impacts from anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is at a stage where it has not spread to distant parts of my body.
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I can care for myself but may not be able to do active work.
Select...
I am using effective birth control.
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I am scheduled for bladder removal surgery soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5years post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5years post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the accuracy of endoscopic assessment in predicting pT0 urothelial disease in the urinary bladder at the time of radical cystectomy.
Secondary outcome measures
To determine how genomic tumor signatures compare before and after chemotherapy administration.
To determine if genomic signature from tissue obtained on endoscopic evaluation just prior to cystectomy can help predict final pathological stage.
To determine if genomic tumor signatures from pre-treatment tumor tissue can predict chemotherapy response.
Side effects data
From 2014 Phase 2 trial • 27 Patients • NCT0038002991%
Rash/desquamation
57%
Hemoglobin
52%
Urinary frequency/urgency
43%
Anorexia
35%
Hypomagnesemia
35%
Fatigue
30%
Hyponatremia
30%
Diarrhea
30%
Hypocalcemia
26%
Creatinine
22%
Hematuria (in the absence of vaginal cleeding)
22%
Hypoalbuminemia
22%
Nausea
17%
Constipation
17%
Alkaline phosphatase
17%
Bicarbonate
17%
Taste disturbance (dysgeusia)
17%
Lymphopenia
17%
Cough
17%
Hypokalemia
13%
Hyperkalemia
13%
Mood alteration- Depression
13%
Infection without neutropenia
13%
Hyperglycemia
13%
Dry skin
13%
SGOT (AST) (serum glutamic oxaloacetic transaminase)
13%
Platelets
9%
Abdominal pain or cramping
9%
Cardiac ischemia/infarction
9%
Ileus (or neuroconstipation)
9%
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
9%
Thrombosis/embolism
9%
Hypernatremia
9%
Dysuria
9%
Pain - Back
9%
GGT (Gamma-Glutamyl transpeptidase)
9%
Vomiting
4%
Tremor
4%
Pain - Abdomen NOS
4%
Alopecia
4%
Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)
4%
Sweating (diaphoresis)
4%
Gastrointestinal-Other (Gastroesophageal reflux disease)
4%
Partial thromboplastin time (PTT)
4%
Hand-foot skin reaction
4%
Bladder spasms
4%
Cardiovascular/Arrhythmia-Afib/tachycardia
4%
Dermatology/Skin-Other (Paronychia)
4%
Dizziness/lightheadedness
4%
Musculoskeletal- Other (Parastomal hernia)
4%
Arthralgia
4%
Lipase
4%
Dermatology/Skin-Other (onychomycosis -on fingers -bilaterally)
4%
Dermatology/Skin-Other (Boils on abdomen)
4%
Infection with unknown ANC
4%
Incontinence
4%
CPK (creatine phosphokinase)
4%
Mood alteration - Anxiety
4%
Musculoskeletal-Other (Gout flare)
4%
Renal/Genitourinary-Other (Candida urinary tract infection (UTI))
4%
Insomnia
4%
Mood alteration - Anxiety, agitation
4%
Syncope
4%
Neuropathy-sensory
4%
Death NOS- Unknown cause
4%
Amylase
4%
Apnea
4%
Dermatology/Skin-Other (Cracked Lips)
4%
Dermatology/Skin-Other (Reynaud's)
4%
Hypoglycemia
4%
Infection/Febrile Neutropenia-Other (Urinary tract infection - intermittent)
4%
Cardiovascular/Arrhythmia-Other (Abnormal EKG)
4%
Gastrointestinal-Other (Mallory-Weiss tear w/nausea, vomiting)
4%
Coagulation-Elevated international normalized ratio (INR)
4%
Hemorrhage-Other (Hemorrhoid)
4%
Hypertension
4%
Hypophosphatemia
4%
Glaucoma
4%
Pruritus
4%
Renal/Genitourinary - Other (Dysuria)
4%
SGPT (ALT) (serum glutamic pyruvic transaminase)
4%
Pain-Other (Cramping - Hands/Feet)
4%
Pain-Other (Pain - rash induced)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: SurgicalExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Cystectomy
2006
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Temple UniversityOTHER
296 Previous Clinical Trials
82,730 Total Patients Enrolled
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,444 Total Patients Enrolled
Alexander Kutikov, MDPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be able to do active work.I can understand and am willing to sign the consent forms myself or have someone who can do it for me.I am over 18 years old.I have not had a cystectomy that was not aimed at curing my condition.I am not pregnant or nursing, as the treatment would be risky for a fetus or infant.My bladder cancer is at a stage where it has not spread to distant parts of my body.I am scheduled for bladder removal surgery soon.I am using effective birth control.I have had radiation treatment to my pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this experiment still open?
"According to information presented on clinicaltrials.gov, this specific trial is no longer recruiting participants, as evidenced by its last update on May 18th 2022. Nevertheless, there are 2744 additional medical trials that currently accept enrollees at present."
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