GlioblatomaNCT00035373
Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute s (NCI) Clinical Research Protocols
An observational study of Glioblatoma and Gliosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The objective of this study is to evaluate patients with tumors of the central nervous system (CNS) for eligibility in the National Cancer Institute s research studies. These patients will undergo a series of procedures, usually including a complete medical history and physical examination; laboratory testing of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glioblatoma, Gliosarcoma, Anaplastic Astrocytoma
- How many people
- 767 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2002to 29 Apr 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than or equal to 18 yrs of age) with tumors of the CNS or a history of a CNS tumor who are being evaluated for protocols within the National Cancer Institute.
- All patients or their previously designated LAR (Legally Authorized Representative) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study and the risks of the procedures that will be performed to assess eligibility for primary research protocols.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute (NCI) Clinical Research Protocols
The objective of this study is to evaluate patients with tumors of the central nervous system (CNS) for eligibility in the National Cancer Institute s research studies. These patients will undergo a series of procedures, usually including a complete medical history and physical examination; laboratory testing of blood, CSF, urine, bone marrow, or other samples; an evaluation of tumor location and size by x-rays, CT (computed tomography) or MRI (magnetic resonance imaging) scans, or nuclear medicine scans; lumbar puncture; electrocardiogram and echocardiogram; and procedures to evaluate the function of specific organs. A bone marrow biopsy is occasionally performed. Research samples may also be collected and stored to avoid having to do a painful test more than once. Tissue specimens collected during this process may be stored and used in future studies.
Patients of both genders, any age, and all racial and ethnic groups with tumors of the CNS or a history of a CNS tumor are eligible. Up to 100 people are expected to participate.
The physician will discuss the results of these procedures with the patient and his or her family. On the basis of the eligibility screening and the patient s wishes, the patient may then be enrolled in a primary research protocol.
Read the detailed description
BACKGROUND:
-Adult patients (greater than or equal to 18 yrs of age) with tumors of the central nervous system who are being evaluated by the Neuro-Oncology Branch (NOB) for National Cancer Institute (NCI) primary research protocols will be entered onto this screening protocol for eligibility screening.
OBJECTIVE:
- Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in National Cancer Institute (NCI) research protocols.
ELIGIBILITY:
- Patients with tumors of the CNS or a history of a CNS tumor who are being evaluated for protocols within the National Cancer Institute.
DESIGN:
- The screening tests and procedures that are required by the primary research protocols will be conducted in order to establish eligibility for these protocols.
- These procedures may include, but are not limited to, laboratory tests on blood, CSF, urine, or other specimens, and radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotopic tracer.
- This protocol will also allow for evaluation of existing tumor specimens to determine if targets are present, when applicable.
- In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to prevent us from having to subject the patient to a painful procedure on multiple occasions (e.g., bone marrow aspirations).
- Research specimens will be discarded, if the patient is not eligible for or elects not to enroll on the primary research protocol. A total of 3000 patients will be enrolled.
- Conditions
- Glioblatoma, Gliosarcoma, Anaplastic Astrocytoma, Oligodendroglioma, Anaplastic Oligoastrocytoma
- Keywords
- Tumor, Brain, Chemotherapy, Anti-Angiogenesis, Radiation Therapy, CNS Tumor
- Medical subject headings
- Gliosarcoma, Astrocytoma, Oligodendroglioma, Neoplasms, Central Nervous System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in National Cancer Institute (NCI) research protocols.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study start19 Apr 2002
- Study completion29 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblatomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine E Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035373
- Sponsor's protocol ID
- 020186
- Other IDs
- 02-C-0186
- Status last verified
- 29 Apr 2015
- First submitted
- 2 May 2002
- Last updated
- 7 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute (NCI) Clinical Research Protocols
- ClinicalTrials.gov ID
- NCT00035373
- Acronym / sponsor ID
- 020186
- Conditions
- Glioblatoma, Gliosarcoma, Anaplastic Astrocytoma, Oligodendroglioma, Anaplastic Oligoastrocytoma
- Keywords
- Tumor, Brain, Chemotherapy, Anti-Angiogenesis, Radiation Therapy, CNS Tumor
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 767 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Apr 2002
- Study completion
- 29 Apr 2015
- First posted
- 3 May 2002 (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.
The objective of this study is to evaluate patients with tumors of the central nervous system (CNS) for eligibility in the National Cancer Institute s research studies. These patients will undergo a series of procedures, usually including a complete medical history and physical examination; laboratory testing of blood, CSF, urine, bone marrow, or other samples; an evaluation of tumor location and size by x-rays, CT (computed tomography) or MRI (magnetic resonance imaging) scans, or nuclear medicine scans; lumbar puncture; electrocardiogram and echocardiogram; and procedures to evaluate the function of specific organs. A bone marrow biopsy is occasionally performed. Research samples may also be collected and stored to avoid having to do a painful test more than once. Tissue specimens collected during this process may be stored and used in future studies.
Patients of both genders, any age, and all racial and ethnic groups with tumors of the CNS or a history of a CNS tumor are eligible. Up to 100 people are expected to participate.
The physician will discuss the results of these procedures with the patient and his or her family. On the basis of the eligibility screening and the patient s wishes, the patient may then be enrolled in a primary research protocol.
Detailed description
BACKGROUND:
-Adult patients (greater than or equal to 18 yrs of age) with tumors of the central nervous system who are being evaluated by the Neuro-Oncology Branch (NOB) for National Cancer Institute (NCI) primary research protocols will be entered onto this screening protocol for eligibility screening.
OBJECTIVE:
- Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in National Cancer Institute (NCI) research protocols.
ELIGIBILITY:
- Patients with tumors of the CNS or a history of a CNS tumor who are being evaluated for protocols within the National Cancer Institute.
DESIGN:
- The screening tests and procedures that are required by the primary research protocols will be conducted in order to establish eligibility for these protocols.
- These procedures may include, but are not limited to, laboratory tests on blood, CSF, urine, or other specimens, and radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotopic tracer.
- This protocol will also allow for evaluation of existing tumor specimens to determine if targets are present, when applicable.
- In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to prevent us from having to subject the patient to a painful procedure on multiple occasions (e.g., bone marrow aspirations).
- Research specimens will be discarded, if the patient is not eligible for or elects not to enroll on the primary research protocol. A total of 3000 patients will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (greater than or equal to 18 yrs of age) with tumors of the CNS or a history of a CNS tumor who are being evaluated for protocols within the National Cancer Institute.
- All patients or their previously designated LAR (Legally Authorized Representative) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study and the risks of the procedures that will be performed to assess eligibility for primary research protocols.
Key exclusion criteria (1 listed)
- None
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
Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in National Cancer Institute (NCI) research protocols.
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
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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.
Katherine E Warren, M.D. principal investigator
National Cancer Institute (NCI)
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 Glioblatoma and Gliosarcoma, run by National Cancer Institute (NCI) 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 2 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: stopped early, as of the sponsor's last update on 7 Nov 2019. 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 was stopped early. 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.
What does the primary outcome measure?
Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in National Cancer Institute (NCI) research protocols. (time frame: Ongoing). 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 7 Nov 2019.