Ewing SarcomaNCT00026780
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
An observational study of Ewing Sarcoma and Osteosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Patients who are being considered for participation in a NCI Pediatric Oncology Branch research study will be screened for eligibility under this protocol. For every NCI research study, patients must meet defined medical criteria in order to ensure the integrity of the research study and to maximize patient safety. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Ewing Sarcoma, Osteosarcoma, Neuroblastoma
- How many people
- 1,720 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2001to 7 Oct 2020
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults who are being evaluated for protocols within the Pediatric Oncology Branch.
Who may be able to join
- Children and young adults who are being evaluated for and treated on protocols within the Pediatric Oncology Branch.
- All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for primary research protocols.
- Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening for eligibility on POB research trials.
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 and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols
Patients who are being considered for participation in a NCI Pediatric Oncology Branch research study will be screened for eligibility under this protocol. For every NCI research study, patients must meet defined medical criteria in order to ensure the integrity of the research study and to maximize patient safety.
Tests and procedures required for determining eligibility depend on the specific study for which the patient is being considered. Some of the more common tests and procedures are:
- History and physical examination
- Blood and urine samples for routine laboratory tests and possibly research studies
- Quality of life assessment questionnaire
- Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce pictures of body structures, including tumors
- Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures of body structures
- X-rays uses radiation to provide a single picture of a body part
- Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid (fluid that bathes the brain and spinal cord)
- Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and rhythm by measuring electrical impulses from the heart
- Echocardiogram uses high-frequency sound waves to evaluate heart structure and function
- Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid. Involves placing a needle into the lower back between the bones of the spine and withdrawing a fluid sample from the fluid-containing space below the spinal cord
- Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles of the brain, used to withdraw spinal fluid samples and to give medication
- Eye examination vision test and eye examination
- Biopsies removal of a small piece of tissue, by needle or by surgery, for examination under the microscope. An area of skin over the biopsy site is numbed with an anesthetic. For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull out a small sample. A surgical biopsy may be done in the operating room, clinic, or hospital room, depending on the biopsy location. The tissue or tumor is removed by cutting a small piece of it with a sharp knife or scalpel and the area will be closed with sutures or staples.
Read the detailed description
BACKGROUND:
- Patients, who are screened for POB research protocols, undergo a series of tests and procedures to determine protocol eligibility prior to entry onto the primary research protocol
- In some cases, specific research samples required for the primary research protocol may becollected during the screening process to prevent subjecting the patient to a painful procedure on multiple occasions.
- Performing invasive procedures for the sole purpose of obtaining tissue specimens or body fluids for research purposes is often not ethically justifiable in children, yet these specimens are needed to advance our knowledge of childhood cancers. Therefore, it is critical to obtain tissue and fluid samples for future research when procedures are performed for clinical indications.
OBJECTIVES:
- Evaluate patient eligibility for participation in POB research protocols.
- Collect clinical data, such as a medical history and clinical laboratory results that can serve as baseline values for subsequent research protocols.
- Procure residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or treatment of the cancer) during the screening process or during treatment and follow-up on a primary POB research protocol. These specimens will be transferred to subsequent research protocols for IRB-approved research studies or stored for future research studies.
ELIGIBILITY:
- Children and young adults who are being evaluated for and treated on protocols within the Pediatric Oncology Branch.
- Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening for eligibility on POB research trials.
DESIGN:
- Patients who are being evaluated for POB primary research protocols will be entered onto this screening and tissue procurement protocol for eligibility screening and collection of tissue specimens.
- Procedures to be done may include, but are not limited to, laboratory tests on blood, CSF, urine, or other specimens; pulmonary function tests; TB skin tests (with a control); subspecialty consultations; molecular diagnostics on tumor tissues such as PCR for Ewing s or rhabdomyosarcoma, HLA, IHC, or FISH; radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotopic tracer; and needle or open biopsies for diagnostic purposes.
- Tissues and body fluids that are obtained during or after the screening process or at any time during treatment and follow-up on a primary POB research protocol will be discarded or stored for future research purposes with the consent of the patient or his/her parent or guardian, if the patient is not eligible for or elects not to enroll on the primary research protocol. These specimens will be stored with patient identifiers, IRB approval will be requested prior to performing any research with these tissues or fluids or the samples will have identifiers removed (unlinked) and an exemption will be requested from OHSRP.
- Conditions
- Ewing Sarcoma, Osteosarcoma, Neuroblastoma, Acute Lymphoblastic Leukemia, Neurofibromatosis Type 1
- Keywords
- CT Scan, MRI Scan, Childhood Cancer, Eligibility Screening, Tissue Procurement, Pediatric, Children, Screening
- Medical subject headings
- Sarcoma, Ewing, Osteosarcoma, Neuroblastoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neurofibromatosis 1, Neoplasms
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 |
|---|---|---|
| Cohort 1 | Children and young adults who are being evaluated for protocols within the Pediatric Oncology Branch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient eligibility
Eligibility
Measured: 1 month
Collect clinical data
Clinical data to determine eligibility
Measured: 1 month
Procure samples
Collect specimens to confirm eligibility
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start24 Sep 2001
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies 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
- 1,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brigitte C Widemann, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026780
- Sponsor's protocol ID
- 010157
- Other IDs
- 01-C-0157
- Status last verified
- Oct 2020
- First submitted
- 14 Nov 2001
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols
- ClinicalTrials.gov ID
- NCT00026780
- Acronym / sponsor ID
- 010157
- Conditions
- Ewing Sarcoma, Osteosarcoma, Neuroblastoma, Acute Lymphoblastic Leukemia, Neurofibromatosis Type 1
- Keywords
- CT Scan, MRI Scan, Childhood Cancer, Eligibility Screening, Tissue Procurement, Pediatric, Children, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,720 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Sep 2001 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 15 Nov 2001 (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.
Patients who are being considered for participation in a NCI Pediatric Oncology Branch research study will be screened for eligibility under this protocol. For every NCI research study, patients must meet defined medical criteria in order to ensure the integrity of the research study and to maximize patient safety.
Tests and procedures required for determining eligibility depend on the specific study for which the patient is being considered. Some of the more common tests and procedures are:
- History and physical examination
- Blood and urine samples for routine laboratory tests and possibly research studies
- Quality of life assessment questionnaire
- Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce pictures of body structures, including tumors
- Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures of body structures
- X-rays uses radiation to provide a single picture of a body part
- Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid (fluid that bathes the brain and spinal cord)
- Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and rhythm by measuring electrical impulses from the heart
- Echocardiogram uses high-frequency sound waves to evaluate heart structure and function
- Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid. Involves placing a needle into the lower back between the bones of the spine and withdrawing a fluid sample from the fluid-containing space below the spinal cord
- Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles of the brain, used to withdraw spinal fluid samples and to give medication
- Eye examination vision test and eye examination
- Biopsies removal of a small piece of tissue, by needle or by surgery, for examination under the microscope. An area of skin over the biopsy site is numbed with an anesthetic. For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull out a small sample. A surgical biopsy may be done in the operating room, clinic, or hospital room, depending on the biopsy location. The tissue or tumor is removed by cutting a small piece of it with a sharp knife or scalpel and the area will be closed with sutures or staples.
Detailed description
BACKGROUND:
- Patients, who are screened for POB research protocols, undergo a series of tests and procedures to determine protocol eligibility prior to entry onto the primary research protocol
- In some cases, specific research samples required for the primary research protocol may becollected during the screening process to prevent subjecting the patient to a painful procedure on multiple occasions.
- Performing invasive procedures for the sole purpose of obtaining tissue specimens or body fluids for research purposes is often not ethically justifiable in children, yet these specimens are needed to advance our knowledge of childhood cancers. Therefore, it is critical to obtain tissue and fluid samples for future research when procedures are performed for clinical indications.
OBJECTIVES:
- Evaluate patient eligibility for participation in POB research protocols.
- Collect clinical data, such as a medical history and clinical laboratory results that can serve as baseline values for subsequent research protocols.
- Procure residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or treatment of the cancer) during the screening process or during treatment and follow-up on a primary POB research protocol. These specimens will be transferred to subsequent research protocols for IRB-approved research studies or stored for future research studies.
ELIGIBILITY:
- Children and young adults who are being evaluated for and treated on protocols within the Pediatric Oncology Branch.
- Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening for eligibility on POB research trials.
DESIGN:
- Patients who are being evaluated for POB primary research protocols will be entered onto this screening and tissue procurement protocol for eligibility screening and collection of tissue specimens.
- Procedures to be done may include, but are not limited to, laboratory tests on blood, CSF, urine, or other specimens; pulmonary function tests; TB skin tests (with a control); subspecialty consultations; molecular diagnostics on tumor tissues such as PCR for Ewing s or rhabdomyosarcoma, HLA, IHC, or FISH; radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotopic tracer; and needle or open biopsies for diagnostic purposes.
- Tissues and body fluids that are obtained during or after the screening process or at any time during treatment and follow-up on a primary POB research protocol will be discarded or stored for future research purposes with the consent of the patient or his/her parent or guardian, if the patient is not eligible for or elects not to enroll on the primary research protocol. These specimens will be stored with patient identifiers, IRB approval will be requested prior to performing any research with these tissues or fluids or the samples will have identifiers removed (unlinked) and an exemption will be requested from OHSRP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Children and young adults who are being evaluated for protocols within the Pediatric Oncology Branch. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults who are being evaluated for protocols within the Pediatric Oncology Branch.
Key inclusion criteria (3 listed)
- Children and young adults who are being evaluated for and treated on protocols within the Pediatric Oncology Branch.
- All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for primary research protocols.
- Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening for eligibility on POB research trials.
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
Patient eligibility
Time frame: 1 month
Eligibility
Collect clinical data
Time frame: 1 month
Clinical data to determine eligibility
Procure samples
Time frame: 1 month
Collect specimens to confirm eligibility
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 8 Oct 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Combination Immunotherapy Targeting Sarcomas
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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.
Brigitte C Widemann, 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 Ewing Sarcoma and Osteosarcoma, 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 3 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 8 Oct 2020. 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.
What does the primary outcome measure?
Patient eligibility (time frame: 1 month). 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 8 Oct 2020.