Central Nervous System LymphomaNCT00967200
Study of Tissue Samples From Patients With Glioma or Other Brain Tumors
An observational study of Central Nervous System Lymphoma, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Central Nervous System Lymphoma
- What is being tested?
- laboratory biomarker analysis and pharmacogenomic studies
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2003to Nov 2015
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathophysiology of gliomas and identification of molecular markers that may predict prognosis and progression or that could identify new therapeutic
Who may be able to join
None listed.
Who cannot join
- No concurrent participation in other trials that require a period of exclusion
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Montpellier
Montpellier, 34295
Clinique Gui de Chauliac
Montpellier, 34295
About this study
Official title: Identification of Genes Involved in the Pathogenesis of Gliomas by Transcriptome Analysis
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue samples from patients with glioma or other brain tumors.
Read the detailed description
OBJECTIVES:
Primary
- To better understand the pathophysiology of gliomas and identify molecular markers that may predict prognosis and progression or that could identify new therapeutic approaches.
Secondary
- To compare gene expression profiles, in terms of response to treatment, and attempt to isolate subgroups of patients with objective response to certain types of chemotherapy or radiotherapy.
OUTLINE: This is a multicenter study.
Biological samples are collected from patients at time of surgery for diagnostic and/or treatment purposes.
- Conditions
- Central Nervous System Lymphoma
- Being tested
- laboratory biomarker analysis, pharmacogenomic studies
- Keywords
- adult anaplastic astrocytoma, adult diffuse astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma, adult subependymal giant cell astrocytoma, adult brain stem glioma, adult choroid plexus tumor, adult craniopharyngioma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, meningeal melanocytoma, adult meningeal hemangiopericytoma
- Medical subject headings
- Astrocytoma, Glioblastoma, Gliosarcoma, Choroid Plexus Neoplasms, Craniopharyngioma, Neuroectodermal Tumors, Primitive, Medulloblastoma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
laboratory biomarker analysis
pharmacogenomic studiesOther
pharmacogenomic studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathophysiology of gliomas
Pathophysiology of gliomas that may predict prognosis and progression or that could identify new therapeutic
Measured: 1 day
Secondary outcomes (1)
Identification of molecular
Identification of molecular markers that may predict prognosis and progression or that could identify new therapeutic
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startNov 2003
- Primary completionJul 2009
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Bauchet, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967200
- Sponsor's protocol ID
- 7745
- Status last verified
- Nov 2015
- First submitted
- 26 Aug 2009
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genes Involved in the Pathogenesis of Gliomas by Transcriptome Analysis
- ClinicalTrials.gov ID
- NCT00967200
- Acronym / sponsor ID
- 7745
- Conditions
- Central Nervous System Lymphoma
- Keywords
- adult anaplastic astrocytoma, adult diffuse astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma, adult subependymal giant cell astrocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Aug 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.
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue samples from patients with glioma or other brain tumors.
Detailed description
OBJECTIVES:
Primary
- To better understand the pathophysiology of gliomas and identify molecular markers that may predict prognosis and progression or that could identify new therapeutic approaches.
Secondary
- To compare gene expression profiles, in terms of response to treatment, and attempt to isolate subgroups of patients with objective response to certain types of chemotherapy or radiotherapy.
OUTLINE: This is a multicenter study.
Biological samples are collected from patients at time of surgery for diagnostic and/or treatment purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathophysiology of gliomas and identification of molecular markers that may predict prognosis and progression or that could identify new therapeutic
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No concurrent participation in other trials that require a period of exclusion
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 |
|---|---|---|
| laboratory biomarker analysislaboratory biomarker analysis | Other | – |
| pharmacogenomic studiespharmacogenomic studies | Other | – |
Primary outcome
Pathophysiology of gliomas
Time frame: 1 day
Pathophysiology of gliomas that may predict prognosis and progression or that could identify new therapeutic
1 secondary outcome
Identification of molecular
Time frame: 1 day
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 24 Nov 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.
Luc Bauchet, MD principal investigator
University Hospital, Montpellier
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 Central Nervous System Lymphoma, run by University Hospital, Montpellier at 2 sites in France.
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 0 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 24 Nov 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 France. 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?
Pathophysiology of gliomas (time frame: 1 day). 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 24 Nov 2015.