Bladder CancerNCT01198808
Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker
An observational study of Bladder Cancer, run by Technical University of Munich at 1 site in Germany.
Trial summary
Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Dec 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients with muscle-invasive bladder cancer, who are referred to the university hospital: Krankenhaus rechts der Isar der Technischen Universität München
Who may be able to join
- Histologically confirmed muscle-invasive urothelial carcinoma
- Age > 18 years
- Hemoglobin > 10g/dl
- Signed Informed Consent
- Karnofsky index < 70%
Who cannot join
- Clinically relevant second malignancy
- Severe comorbidities (e.g. NYHA III, end-stage renal disease)
- Chronic infectious disease (HIV, Tuberculosis)
- Immunosupression
- Severe psychiatric diseases
- Blood donation in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Urologische Klinik der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters
Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy.
It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, chemotherapy, T cells, Immunotherapy, Tumor-specific immunity in bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
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 Technical University of MunichThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Horn, MD, Principal investigator, Department of Urology, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198808
- Sponsor's protocol ID
- IBT-1
- Status last verified
- Jan 2012
- First submitted
- 8 Sep 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters
- ClinicalTrials.gov ID
- NCT01198808
- Acronym / sponsor ID
- IBT-1
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, chemotherapy, T cells, Immunotherapy, Tumor-specific immunity in bladder cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- First posted
- 10 Sep 2010 (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.
Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy.
It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with muscle-invasive bladder cancer, who are referred to the university hospital: Krankenhaus rechts der Isar der Technischen Universität München
Key inclusion criteria (5 listed)
- Histologically confirmed muscle-invasive urothelial carcinoma
- Age > 18 years
- Hemoglobin > 10g/dl
- Signed Informed Consent
- Karnofsky index < 70%
Key exclusion criteria (6 listed)
- Clinically relevant second malignancy
- Severe comorbidities (e.g. NYHA III, end-stage renal disease)
- Chronic infectious disease (HIV, Tuberculosis)
- Immunosupression
- Severe psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Thomas Horn, MD principal investigator
Department of Urology, Technische Universität München
1 site 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 Technical University of Munich at 1 site in Germany.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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.
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 18 Jan 2012.