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UC Subjects for Bladder Cancer

N/A

Waitlist Available

Research Sponsored by Matthew Milowsky, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of consent and retained indefinitely (estimate 10 years)

Awards & highlights

Study Summary

This trial uses next generation sequencing to study the genetic mutations of 200 subjects with metastatic urothelial cancer. The goal is to identify subject specific genetic mutations and store DNA and RNA extracted from the tumor specimens for future research.

Eligible Conditions

Bladder Cancer
Urethral Cancer
Ureteral Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of consent and retained indefinitely (estimate 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of consent and retained indefinitely (estimate 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of consent and retained indefinitely (estimate 10 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Collection of tissue and blood samples from subjects receiving treatment for urothelial cancer

Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options

Secondary outcome measures

Collect comprehensive clinical outcomes for all subjects enrolled in this clinical trial

Collect comprehensive demographic data for all subjects enrolled in this clinical trial

Collect comprehensive treatment histories for all subjects enrolled in this clinical trial

+5 more

Side effects data

From 2024 Phase 2 trial • 86 Patients • NCT03201458

74%

Disease Progression

47%

Fatigue

35%

Aspartate aminotransferase (AST) increased

33%

Abdominal pain

33%

Diarrhea

30%

Hypertension

30%

Lymphocyte count decreased

30%

Anemia

28%

Hyponatremia

28%

Alkaline phosphatase increased

28%

Nausea

26%

Hypoalbuminemia

26%

Hypokalemia

23%

Alanine aminotransferase (ALT) increased

23%

Vomiting

21%

Fever

21%

Platelet count decreased

21%

Anorexia

21%

Cough

19%

Pain

16%

Blood bilirubin increased

16%

Constipation

16%

White blood cell decreased

14%

Dyspnea

14%

Creatinine increased

12%

Hypomagnesemia

12%

Bloating

12%

Chills

12%

Dehyrdation

12%

Weight loss

Hypothyroidism

Rash

Dizziness

Edema

Headache

Infusion-related reaction

Hypotension

Ascites

Back pain

Hypophosphotemia

Allergic reaction

Neutrophil count decreased

Dyspepsia

Thrush

Hypercalcemia

Hyperglycemia

Hypocalcemia

Myalgia

Gastric obstruction

Insomnia

Malaise

Proteinuria

Allergic rhinitis

Dysgeusia

Dysphagia

Flatulence

Generalized muscle weakness

Non-cardiac chest pain

Oral pain

Peripheral neuropathy

Pleural effusion

Pruritus

Sinus tachycardia

Colitis

Death NOS

Abdominal distension

Anxiety

Arthralgia

Hyperhidrosis

Biliary tract infection

Gastroesophageal reflux disease (GERD)

Presyncope

Myocarditis

Biliary duct obstruction

Hyperkalemia

Syncope

Cardiac troponin increased

Duodenal obstruction

Lipase increased

Pleuritic pain

Edema limbs

Encephalopathy

Hypoxia

Ileal obstruction

Myocardial infarction

Sepsis

Ureteral obstruction

Urinary retention

Dry mouth

Dry skin

Sinus bradycardia

Sore throat

Bacteremia

Fungemia

Infusion related reaction

Meningitis

Peritoneal infection

Viral infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Atezolizumab)

Arm B (Atezolizumab, Cobimetinib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: UC SubjectsExperimental Treatment1 Intervention

Subjects with confirmed metastatic urothelial cancer willing to participate in biospecimen collection (tissue and blood) for genetic studies.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Matthew Milowsky, MDLead Sponsor

Bladder Cancer Advocacy Network (BCAN®)UNKNOWN

Hoosier Cancer Research NetworkOTHER

68 Previous Clinical Trials

3,536 Total Patients Enrolled

Media Library

UC Subjects Clinical Trial Eligibility Overview. Trial Name: NCT02643043 — N/A

Bladder Cancer Research Study Groups: UC Subjects

Bladder Cancer Clinical Trial 2023: UC Subjects Highlights & Side Effects. Trial Name: NCT02643043 — N/A

UC Subjects 2023 Treatment Timeline for Medical Study. Trial Name: NCT02643043 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care facilities are presently conducting this research project?

"The University of Southern California in Los Angeles, the University of Chicago Medical Centre in Illinois, and Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Maryland are all hosting this clinical trial. Additionally, there are 8 other medical sites participating as well."

Answered by AI

Is enrollment for this scientific investigation still available?

"According to clinicaltrials.gov, this medical study is no longer open for recruitment; its initial posting was on July 26th 2017 and the last edit occurred on February 14th 2022. However, there are still 317 other active studies seeking participants at this moment in time."

Answered by AI

What are the foremost goals of this exploration?

"The primary outcome of this clinical trial, spanning across two weeks from consent to the receipt of next-generation sequencing (NGS) results, is to collect tissue and blood samples from patients receiving urothelial cancer treatment. Secondary objectives encompass collecting comprehensive demographic data for all participants enrolled in this study - archived on a secure platform - as well as comparing overall survival rates between those who receive targeted therapy based on their NGS results and those that do not."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch

Matthew Milowsky, MD 2017. "UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02643043.