NCT00872495

Brief Summary

The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of urothelial cancer of the bladder and kidney. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2002Nov 2028

Study Start

First participant enrolled

September 1, 2002

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
19.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

26.1 years

First QC Date

March 27, 2009

Last Update Submit

December 1, 2025

Conditions

CancerBladder NeoplasmsUrinary Bladder CancerUrothelial Cancer

Keywords

Urothelial CancerCancerBladder NeoplasmsUrinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the utility of emerging technologies in the detection of bladder tumor cells using non-invasive approaches utilizing voided urine samples.

    Ongoing Lab analysis for study duration: final data completion date

Study Arms (2)

1

Bladder Cancer Group: Patients scheduled to have a cystectomy or cystoscopy of their bladder with possible removal or biopsy of bladder tumor or tissue. Two urine samples collected at the time of the scheduled procedure: One sample collected through voiding. The other sample collected from atheterized urine in the operating room. Additional urine samples may be collected at each follow up visit over two years. These samples will be obtained via voiding, standard urine sample collection.

2

Control Group: Patients with no known evidence of bladder cancer. One urine sample will be collected through voiding, as with standard urine sample collection at the time of clinic visit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lahey Clinic patients presenting to the Department of Urology and Primary Care Referrals

You may qualify if:

  • Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)
  • Control Group: No known evidence of bladder cancer-one urine sample
  • \> than 18 years of age

You may not qualify if:

  • \< than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

RECRUITING

Related Publications (4)

  • Sidransky D, Von Eschenbach A, Tsai YC, Jones P, Summerhayes I, Marshall F, Paul M, Green P, Hamilton SR, Frost P, et al. Identification of p53 gene mutations in bladder cancers and urine samples. Science. 1991 May 3;252(5006):706-9. doi: 10.1126/science.2024123.

    PMID: 2024123BACKGROUND

  • Levesque P, Ramchurren N, Saini K, Joyce A, Libertino J, Summerhayes IC. Screening of human bladder tumors and urine sediments for the presence of H-ras mutations. Int J Cancer. 1993 Nov 11;55(5):785-90. doi: 10.1002/ijc.2910550516.

    PMID: 7902340BACKGROUND

  • Fitzgerald JM, Ramchurren N, Rieger K, Levesque P, Silverman M, Libertino JA, Summerhayes IC. Identification of H-ras mutations in urine sediments complements cytology in the detection of bladder tumors. J Natl Cancer Inst. 1995 Jan 18;87(2):129-33. doi: 10.1093/jnci/87.2.129.

    PMID: 7707384BACKGROUND

  • Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. doi: 10.1002/cncr.11536.

    PMID: 12910517BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Kimberly Rieger-Christ, PhD

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Rieger-Christ, PhD

CONTACT

781-744-2969Kimberly.R.Christ@lahey.org

Linda M. Topjian

CONTACT

781-744-8711Linda.M.Topjian@Lahey.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 31, 2009

Study Start

September 1, 2002

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations

US(1)