Brain and Central Nervous System TumorsNCT00897858
Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
An observational study of Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 8 sites in United States.
Trial summary
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2006to Jan 2014
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of newly diagnosed pediatric patients with a CNS tumor and no prior irradiation or chemotherapy. Cerebrospinal fluid (CSF) is withdrawn as part of initial diagnosis/staging, the administration of intrathecal therapy, or CSF diversion.
DISEASE CHARACTERISTICS:
- Histologically confirmed CNS tumors of any of the following histologies:
- Diffuse pontine gliomas*
- Focal/infiltrative tumors, including any of the following:
- High- and low-grade gliomas
- Gangliogliomas
- Ependymomas
- Oligodendrogliomas
- Craniopharyngioma
- Dysembryoplastic neuroepithelial tumors
- Other low-grade neoplasms
- Optic pathway gliomas*
- Seeding tumors, including any of the following:
- Germ cell tumors (germinomas and nongerminomas)
- Embryonal tumors, including any of the following:
- Medulloblastoma
- Pineoblastoma
- Supratentorial primitive neuroectodermal tumors
- Atypical teratoid/rhabdoid tumor
- Other embryonal tumors NOTE: *Histological requirement waived
- Newly diagnosed disease
- Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)
PATIENT CHARACTERISTICS:
- Less than 22 years of age
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- Prior corticosteroids allowed
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, 77030-2399
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.
Read the detailed description
OBJECTIVES:
Primary
- Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
- Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.
OUTLINE: This is a multicenter study.
Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).
CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood atypical teratoid/rhabdoid tumor, untreated childhood visual pathway glioma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma, childhood craniopharyngioma, untreated childhood medulloblastoma, untreated childhood cerebellar astrocytoma, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood brain stem glioma, untreated childhood visual pathway and hypothalamic glioma, childhood high-grade cerebral astrocytoma, childhood low-grade cerebral astrocytoma, childhood central nervous system choriocarcinoma, childhood central nervous system embryonal tumor
- Medical subject headings
- Central Nervous System Neoplasms, Choroid Plexus Neoplasms, Rhabdoid Tumor, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric CNS tumor patients | Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IRB approvals of the study
IRB approval will be used as a surrogate marker of support for this protocol.
Measured: Within 120 days of study release
Number of patients with proteomic data received at the Operations and Biostatistics Center
Feasibility implies registering patients, submitting samples for proteomic investigation, and successfully analyzing the data at the lab in a timely fashion. The number of patients with proteomic data received at the PBTC Operations and Biostatistics Center will be assessed at 12, 18, 24, and 30 months after the 4th institution receives IRB approval for the study.
Measured: 12, 18, 24, and 30 months after 4th IRB approval
Number of differentially expressed biomarker proteins
Unsupervised proteomic profiling will be done on the CSF samples obtained pre-treatment in order to identify proteins that differ between pediatric brain tumor patients and a banked set of pediatric control "normal" samples.
Measured: Pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2006
- Primary completionJan 2014 (estimated)
Why it stopped: This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian R. Rood, MD, Study chair, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897858
- Sponsor's protocol ID
- CDR0000481330
- Other IDs
- PBTC-N08
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors
- ClinicalTrials.gov ID
- NCT00897858
- Acronym / sponsor ID
- CDR0000481330
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood atypical teratoid/rhabdoid tumor, untreated childhood visual pathway glioma, childhood infratentorial ependymoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pediatric Brain Tumor ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2006
- Primary completion
- Jan 2014 (estimated)
- First posted
- 12 May 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 samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.
Detailed description
OBJECTIVES:
Primary
- Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
- Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.
OUTLINE: This is a multicenter study.
Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).
CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric CNS tumor patients | – | –Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of newly diagnosed pediatric patients with a CNS tumor and no prior irradiation or chemotherapy. Cerebrospinal fluid (CSF) is withdrawn as part of initial diagnosis/staging, the administration of intrathecal therapy, or CSF diversion.
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
Number of IRB approvals of the study
Time frame: Within 120 days of study release
IRB approval will be used as a surrogate marker of support for this protocol.
Number of patients with proteomic data received at the Operations and Biostatistics Center
Time frame: 12, 18, 24, and 30 months after 4th IRB approval
Feasibility implies registering patients, submitting samples for proteomic investigation, and successfully analyzing the data at the lab in a timely fashion. The number of patients with proteomic data received at the PBTC Operations and Biostatistics Center will be assessed at 12, 18, 24, and 30 months after the 4th institution receives IRB approval for the study.
Number of differentially expressed biomarker proteins
Time frame: Pre-treatment
Unsupervised proteomic profiling will be done on the CSF samples obtained pre-treatment in order to identify proteins that differ between pediatric brain tumor patients and a banked set of pediatric control "normal" samples.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
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.
Brian R. Rood, MD study chair
Children's National Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 8 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?
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: withdrawn, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 withdrawn before enrolling participants, so there are no results.
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?
Number of IRB approvals of the study (time frame: Within 120 days of study release). The study lists 3 primary outcomes in all. 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 19 Apr 2013.