Neoplasms, Urinary BladderNCT01706185
Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
An observational study of Neoplasms, Urinary Bladder, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Urinary Bladder
- What is being tested?
- Data acquisition and analysis
- How many people
- 156 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2008to 15 Jan 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previously collected samples and data of patients with pathologically demonstrated bladder cancer.
Who may be able to join
- For inclusion of a tissue sample, all of the following criteria must be met:
- The patient had pathologically proven bladder cancer (any stage).
- All the data required are available from patient's records.
- There are no restrictions regarding operative technique (cystectomy or cystoscopy).
- Many patients may no longer be alive, or no longer be in contact with the investigation sites. Thus, patients will not be required to give their informed consent before inclusion in the study.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.
Read the detailed description
There will be no procedure(s) or treatment(s) carried out on patients. All data and samples will be taken from those already stored at the investigation sites. Clinical data collected will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system) [TNM stage], and histopathologic description only. Strict anonymity of patient data will be maintained.
This retrospective study is based upon the analysis of archived formalin-fixed paraffin-embedded tissue samples and patient-related data already available at the investigational site.
- Conditions
- Neoplasms, Urinary Bladder
- Being tested
- Data acquisition and analysis
- Keywords
- Patients, Tumor antigens, Bladder cancer
- 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.
Data acquisition and analysisOther
Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Group | Not described Receives: Other: Data acquisition and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start15 Jan 2008
- Primary completion15 Jan 2008
- Study completion15 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Urinary BladderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706185
- Sponsor's protocol ID
- 111294
- Status last verified
- Jul 2018
- First submitted
- 4 Oct 2012
- Last updated
- 31 Jul 2018
- Results posted
- No
Publications
Lerut E, Van Poppel H, Joniau S, Gruselle O, Coche T, Therasse P. Rates of MAGE-A3 and PRAME expressing tumors in FFPE tissue specimens from bladder cancer patients: potential targets for antigen-specific cancer immunotherapeutics. Int J Clin Exp Pathol. 2015 Aug 1;8(8):9522-32. eCollection 2015.
PubMed 26464715
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
- ClinicalTrials.gov ID
- NCT01706185
- Acronym / sponsor ID
- 111294
- Conditions
- Neoplasms, Urinary Bladder
- Keywords
- Patients, Tumor antigens, Bladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2008 (actual)
- Primary completion
- 15 Jan 2008 (actual)
- Study completion
- 15 Jan 2008 (actual)
- First posted
- 15 Oct 2012 (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.
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.
Detailed description
There will be no procedure(s) or treatment(s) carried out on patients. All data and samples will be taken from those already stored at the investigation sites. Clinical data collected will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system) [TNM stage], and histopathologic description only. Strict anonymity of patient data will be maintained.
This retrospective study is based upon the analysis of archived formalin-fixed paraffin-embedded tissue samples and patient-related data already available at the investigational site.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Group | – | Other: Data acquisition and analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously collected samples and data of patients with pathologically demonstrated bladder cancer.
Key inclusion criteria (5 listed)
- The patient had pathologically proven bladder cancer (any stage).
- All the data required are available from patient's records.
- There are no restrictions regarding operative technique (cystectomy or cystoscopy).
- Many patients may no longer be alive, or no longer be in contact with the investigation sites. Thus, patients will not be required to give their informed consent before inclusion in the study.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| Data acquisition and analysisTumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer. | Other | Cancer Group |
Primary outcome
To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 26464715Lerut E, Van Poppel H, Joniau S, Gruselle O, Coche T, Therasse P. Rates of MAGE-A3 and PRAME expressing tumors in FFPE tissue specimens from bladder cancer patients: potential targets for antigen-specific cancer immunotherapeutics. Int J Clin Exp Pathol. 2015 Aug 1;8(8):9522-32. eCollection 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Neoplasms, Urinary Bladder, run by GlaxoSmithKline at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 31 Jul 2018. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706185, which also lists 1 linked publication.
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 31 Jul 2018.