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TerminatedNCT00918008Updated Mar 6, 2015

A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

An observational study in Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Terminated at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Why this study was terminated
Lack of accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
Male
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Study summary

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.

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Conditions studied

  • Bladder Cancer

Keywords

  • URINARY BLADDER
  • Bladder
  • Blood sample
  • Lymph Nodes
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 12 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be recruited from the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, and from the Department of Surgery, Urology Service at Memorial Sloan-Kettering Cancer Center.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Blood sample

    the blood sample only collected prior to surgery

    Genetic: Blood draw

Interventions

  • GeneticBlood draw

    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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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

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Study locations

2 sites
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • New York Presbyterian Hospital-Weill Medical College of Cornell University
    New York, New York 10065, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00918008
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York Presbyterian Hospital, Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jun 11, 2009
Start date
Jun 2009
Primary completion
May 2011
Completion
May 2011
Last update
Mar 6, 2015

Study contacts

Guido Dalbagni, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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