GliomaNCT00059020
The Role of Gene Changes in Brain Tumor Formation and Growth
An observational study of Glioma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine tissue from gliomas (a type of brain tumor) removed during surgery for gene mutations, or changes, thought to be involved in tumor formation and growth. One common gene mutation causes the receptor for a protein called epidermal growth factor (EGF) to be in an active state all of the time… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Nov 2004
- 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
Who may be able to join
- Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with known primary neoplasms of the CNS.
- Medically indicated diagnostic and/or therapeutic tumor resection.
- Informed consent from patient, age 18 or older to 75 years of age.
- Females of child-bearing capacity: Pregnant women will be entered into the study for tumor collection, but blood will not be drawn at the time of surgery. Six weeks or more after the completion of pregnancy, these women will be contacted and 10cc (2 tsp) of blood will be collected for genotyping.
- No racial or ethnic group or gender is excluded.
Who cannot join
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: EGF Polymorphisms and Gliomagenesis
This study will examine tissue from gliomas (a type of brain tumor) removed during surgery for gene mutations, or changes, thought to be involved in tumor formation and growth. One common gene mutation causes the receptor for a protein called epidermal growth factor (EGF) to be in an active state all of the time, allowing uncontrolled cell growth that can lead to tumor formation. This study will analyze blood and tumor tissue samples from patients with gliomas for:
- Changes in the EGF gene in the tumor
- Changes in other genes, such as that for the EGF receptor (EGFR)
- Changes in levels of EGF and EGFR, and in other proteins and genes that respond to changes in the levels of these proteins in the tumor
- Changes in the EGF gene and protein in the blood
Read more
The study will also determine if production of EGF and EGFR obtained from glioma and from blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in culture.
Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment may be eligible for this study.
Participants will be admitted to the NIH Clinical Center for about 3 to 10 days. They will have a physical and neurological examination, blood and urine tests, other tests, if medically necessary, and will be evaluated and prepared for surgery. During surgery, as much of the tumor as possible will be removed. A small amount of the tumor tissue will be collected for this study. No tissue will be removed for this study that would not otherwise have been removed. Some of the tissue will be used to culture glioma cells and the rest will be frozen and stored for examination, as described above. If any normal-appearing brain tissue is removed during surgery in order to enhance safety in removing the tumor, the normal tissue will be studied as well. Brain tissue that appears normal will not be removed strictly for research.
During surgery and the day after surgery, a blood sample will be drawn from a catheter (plastic tube) that was placed in an artery or vein for surgery. If catheters are no longer in place, blood will be drawn through a needle in a vein.
Read the detailed description
The epidermal growth factor (EGF) is an important biological mediator of normal growth and repair and is critical to epithelial tissue development and maturation of the central nervous system, among other functions. EGF is a natural focus of interest in cancer research because of its influence over mitogenesis, proliferation, and tumorigenesis. In addition, unregulated expression of its receptor, EGFR, has been identified as a common event in neoplastic transformation. In patients with the most malignant primary tumor of the brain, the glioblastoma multiforme (GBM), alterations in the EGFR or in its expression levels have been identified in approximately 50% of patients. We postulate that EGF-EGFR interactions may be important for the development, progression, and prognosis of human gliomas and that alterations of the EGF gene may predict the potential for glioma progression and the severity of disease.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s) seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research. Blood samples will also be collected. Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank; these anonymous donors will serve as controls.
- Conditions
- Glioma
- Keywords
- Glioma, Brain Tumor, Epidermal Growth Factor, Polymorphisms
- Medical subject headings
- Glioma, Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startApr 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Enrolment
- 344 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059020
- Sponsor's protocol ID
- 030160
- Other IDs
- 03-N-0160
- Status last verified
- Nov 2004
- First submitted
- 16 Apr 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Burdick JS, Chung E, Tanner G, Sun M, Paciga JE, Cheng JQ, Washington K, Goldenring JR, Coffey RJ. Treatment of Menetrier's disease with a monoclonal antibody against the epidermal growth factor receptor. N Engl J Med. 2000 Dec 7;343(23):1697-701. doi: 10.1056/NEJM200012073432305. No abstract available.
PubMed 11106719Groenen LC, Nice EC, Burgess AW. Structure-function relationships for the EGF/TGF-alpha family of mitogens. Growth Factors. 1994;11(4):235-57. doi: 10.3109/08977199409010997.
PubMed 7779404Laurence DJ, Gusterson BA. The epidermal growth factor. A review of structural and functional relationships in the normal organism and in cancer cells. Tumour Biol. 1990;11(5):229-61.
PubMed 2203137
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGF Polymorphisms and Gliomagenesis
- ClinicalTrials.gov ID
- NCT00059020
- Acronym / sponsor ID
- 030160
- Conditions
- Glioma
- Keywords
- Glioma, Brain Tumor, Epidermal Growth Factor, Polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 2003
- Study completion
- Nov 2004
- First posted
- 16 Apr 2003 (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 will examine tissue from gliomas (a type of brain tumor) removed during surgery for gene mutations, or changes, thought to be involved in tumor formation and growth. One common gene mutation causes the receptor for a protein called epidermal growth factor (EGF) to be in an active state all of the time, allowing uncontrolled cell growth that can lead to tumor formation. This study will analyze blood and tumor tissue samples from patients with gliomas for:
- Changes in the EGF gene in the tumor
- Changes in other genes, such as that for the EGF receptor (EGFR)
- Changes in levels of EGF and EGFR, and in other proteins and genes that respond to changes in the levels of these proteins in the tumor
- Changes in the EGF gene and protein in the blood
The study will also determine if production of EGF and EGFR obtained from glioma and from blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in culture.
Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment may be eligible for this study.
Participants will be admitted to the NIH Clinical Center for about 3 to 10 days. They will have a physical and neurological examination, blood and urine tests, other tests, if medically necessary, and will be evaluated and prepared for surgery. During surgery, as much of the tumor as possible will be removed. A small amount of the tumor tissue will be collected for this study. No tissue will be removed for this study that would not otherwise have been removed. Some of the tissue will be used to culture glioma cells and the rest will be frozen and stored for examination, as described above. If any normal-appearing brain tissue is removed during surgery in order to enhance safety in removing the tumor, the normal tissue will be studied as well. Brain tissue that appears normal will not be removed strictly for research.
During surgery and the day after surgery, a blood sample will be drawn from a catheter (plastic tube) that was placed in an artery or vein for surgery. If catheters are no longer in place, blood will be drawn through a needle in a vein.
Detailed description
The epidermal growth factor (EGF) is an important biological mediator of normal growth and repair and is critical to epithelial tissue development and maturation of the central nervous system, among other functions. EGF is a natural focus of interest in cancer research because of its influence over mitogenesis, proliferation, and tumorigenesis. In addition, unregulated expression of its receptor, EGFR, has been identified as a common event in neoplastic transformation. In patients with the most malignant primary tumor of the brain, the glioblastoma multiforme (GBM), alterations in the EGFR or in its expression levels have been identified in approximately 50% of patients. We postulate that EGF-EGFR interactions may be important for the development, progression, and prognosis of human gliomas and that alterations of the EGF gene may predict the potential for glioma progression and the severity of disease.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s) seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research. Blood samples will also be collected. Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank; these anonymous donors will serve as controls.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographic evidence of a primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with known primary neoplasms of the CNS.
- Medically indicated diagnostic and/or therapeutic tumor resection.
- Informed consent from patient, age 18 or older to 75 years of age.
- Females of child-bearing capacity: Pregnant women will be entered into the study for tumor collection, but blood will not be drawn at the time of surgery. Six weeks or more after the completion of pregnancy, these women will be contacted and 10cc (2 tsp) of blood will be collected for genotyping.
- No racial or ethnic group or gender is excluded.
Key exclusion criteria (2 listed)
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
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
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 4 Mar 2008.
- Background: PubMed 11106719Burdick JS, Chung E, Tanner G, Sun M, Paciga JE, Cheng JQ, Washington K, Goldenring JR, Coffey RJ. Treatment of Menetrier's disease with a monoclonal antibody against the epidermal growth factor receptor. N Engl J Med. 2000 Dec 7;343(23):1697-701. doi: 10.1056/NEJM200012073432305. No abstract available.
- Background: PubMed 7779404Groenen LC, Nice EC, Burgess AW. Structure-function relationships for the EGF/TGF-alpha family of mitogens. Growth Factors. 1994;11(4):235-57. doi: 10.3109/08977199409010997.
- Background: PubMed 2203137Laurence DJ, Gusterson BA. The epidermal growth factor. A review of structural and functional relationships in the normal organism and in cancer cells. Tumour Biol. 1990;11(5):229-61.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glioma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site 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 5 inclusion and 2 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 4 Mar 2008. 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 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059020, which also lists 3 linked publications.
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 4 Mar 2008.