Bladder CancerNCT00918008
A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
An observational study of Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Blood draw
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065
About this study
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.
- Conditions
- Bladder Cancer
- Being tested
- Blood draw
- Keywords
- URINARY BLADDER, Bladder, Blood sample, Lymph Nodes
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | the blood sample only collected prior to surgery Receives: Genetic: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Guido Dalbagni, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918008
- Sponsor's protocol ID
- 09-054
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2009
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer
- ClinicalTrials.gov ID
- NCT00918008
- Acronym / sponsor ID
- 09-054
- Conditions
- Bladder Cancer
- Keywords
- URINARY BLADDER, Bladder, Blood sample, Lymph Nodes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital, Weill Medical College of Cornell University
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | – | Genetic: Blood drawthe blood sample only collected prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawThe 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. | Genetic | Blood sample |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Bladder Cancer
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
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A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Dalbagni, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.