Non-Metastatic Ewings SarcomaNCT00339898
Prognostic Value of a Positive RT-PCR Test in Patients With Ewing Sarcoma
An observational study of Non-Metastatic Ewings Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will determine whether the results of a test called reverse transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients with Ewing sarcoma, and if they can be used to help identify patients at high risk for metastasis (spread of the cancer beyond the original site). Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Non-Metastatic Ewings Sarcoma
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2004to 13 Jan 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 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients enrolled on COG AEWS0031 are eligible for this study.
Who cannot join
- Patients who were enrolled but from whom samples were not obtained will not be enrolled on this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
This study will determine whether the results of a test called reverse transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients with Ewing sarcoma, and if they can be used to help identify patients at high risk for metastasis (spread of the cancer beyond the original site).
This is a companion study to another NCI trial (AEWS0031), which is examining the effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3 weeks; and 2) if certain biological characteristics of these tumors can predict how well the chemotherapy will work.
Read more
Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have spread, however, are not cured with standard treatment. A goal of future therapy is to identify patients at highest risk for metastasis so that they can be given more intensive therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment.
Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures re required; RT-PCR testing will be performed on blood and bone marrow samples collected for AEWS0031.
...
Read the detailed description
BACKGROUND: Clinical evidence for metastatic disease at the time of diagnosis is an indicator of poor prognosis in Ewing's sarcoma. Patients with non-metastatic disease at presentation are thought to have a better prognosis than those with metastatic disease. Unfortunately, patients who appear non-metastatic at presentation may relapse after initiating or completing standard therapy for Ewing's sarcoma. Evidence of metastatic disease may be determined by radiographic studies and biopsy of potential site(s) of disease. It is possible to identify submicroscopic Ewing's sarcoma cells in blood and bone marrow, yet the prognostic value of this finding is unclear.
OBJECTIVES: To determine the incidence of RT PCR positivity in the blood and bone marrow of patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR positivity.
ELIGIBILITY: Concurrent enrollment on COG AEWS0031.
DESIGN: This is a Companion Biology Study, enrolling approximately 500 patients. All specimens will be evaluated for translocations, it is anticipated that approximately 30% of specimens will have RT PCR positivity. Specimens are collected at the time of diagnosis, prior to cycle 2 chemotherapy, prior to initiation of local control, and at the end of therapy/follow up. Batched specimens are provided to the NIH by the Cooperative Human Tissue Network (CHTN). Following the completion of the COG trial and appropriate follow up periods, RT PCR positivity will be compared with clinical outcome to determine prognostic value.
- Conditions
- Non-Metastatic Ewings Sarcoma
- Keywords
- Minimal Residual Disease, Ewings Sarcoma
- Medical subject headings
- Neoplasm, Residual, Sarcoma, Ewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start12 Mar 2004
- Study completion13 Jan 2015
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 Non-Metastatic Ewings 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
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Crystal L Mackall, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339898
- Sponsor's protocol ID
- 999904135
- Other IDs
- 04-C-N135
- Status last verified
- 13 Jan 2015
- First submitted
- 19 Jun 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Grier HE, Krailo MD, Tarbell NJ, Link MP, Fryer CJ, Pritchard DJ, Gebhardt MC, Dickman PS, Perlman EJ, Meyers PA, Donaldson SS, Moore S, Rausen AR, Vietti TJ, Miser JS. Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone. N Engl J Med. 2003 Feb 20;348(8):694-701. doi: 10.1056/NEJMoa020890.
PubMed 12594313West DC, Grier HE, Swallow MM, Demetri GD, Granowetter L, Sklar J. Detection of circulating tumor cells in patients with Ewing's sarcoma and peripheral primitive neuroectodermal tumor. J Clin Oncol. 1997 Feb;15(2):583-8. doi: 10.1200/JCO.1997.15.2.583.
PubMed 9053480Pfleiderer C, Zoubek A, Gruber B, Kronberger M, Ambros PF, Lion T, Fink FM, Gadner H, Kovar H. Detection of tumour cells in peripheral blood and bone marrow from Ewing tumour patients by RT-PCR. Int J Cancer. 1995 Apr 21;64(2):135-9. doi: 10.1002/ijc.2910640211.
PubMed 7542227
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Prognostic Relevance of PCR Positivity in Blood and Bone Marrow in Non-Metastatic Ewings Sarcoma
- ClinicalTrials.gov ID
- NCT00339898
- Acronym / sponsor ID
- 999904135
- Conditions
- Non-Metastatic Ewings Sarcoma
- Keywords
- Minimal Residual Disease, Ewings Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Mar 2004
- Study completion
- 13 Jan 2015
- First posted
- 21 Jun 2006 (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 determine whether the results of a test called reverse transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients with Ewing sarcoma, and if they can be used to help identify patients at high risk for metastasis (spread of the cancer beyond the original site).
This is a companion study to another NCI trial (AEWS0031), which is examining the effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3 weeks; and 2) if certain biological characteristics of these tumors can predict how well the chemotherapy will work.
Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have spread, however, are not cured with standard treatment. A goal of future therapy is to identify patients at highest risk for metastasis so that they can be given more intensive therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment.
Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures re required; RT-PCR testing will be performed on blood and bone marrow samples collected for AEWS0031.
...
Detailed description
BACKGROUND: Clinical evidence for metastatic disease at the time of diagnosis is an indicator of poor prognosis in Ewing's sarcoma. Patients with non-metastatic disease at presentation are thought to have a better prognosis than those with metastatic disease. Unfortunately, patients who appear non-metastatic at presentation may relapse after initiating or completing standard therapy for Ewing's sarcoma. Evidence of metastatic disease may be determined by radiographic studies and biopsy of potential site(s) of disease. It is possible to identify submicroscopic Ewing's sarcoma cells in blood and bone marrow, yet the prognostic value of this finding is unclear.
OBJECTIVES: To determine the incidence of RT PCR positivity in the blood and bone marrow of patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR positivity.
ELIGIBILITY: Concurrent enrollment on COG AEWS0031.
DESIGN: This is a Companion Biology Study, enrolling approximately 500 patients. All specimens will be evaluated for translocations, it is anticipated that approximately 30% of specimens will have RT PCR positivity. Specimens are collected at the time of diagnosis, prior to cycle 2 chemotherapy, prior to initiation of local control, and at the end of therapy/follow up. Batched specimens are provided to the NIH by the Cooperative Human Tissue Network (CHTN). Following the completion of the COG trial and appropriate follow up periods, RT PCR positivity will be compared with clinical outcome to determine prognostic value.
Study design
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients enrolled on COG AEWS0031 are eligible for this study.
Key exclusion criteria (1 listed)
- Patients who were enrolled but from whom samples were not obtained will not be enrolled on this study.
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 17 Dec 2019.
- Background: PubMed 12594313Grier HE, Krailo MD, Tarbell NJ, Link MP, Fryer CJ, Pritchard DJ, Gebhardt MC, Dickman PS, Perlman EJ, Meyers PA, Donaldson SS, Moore S, Rausen AR, Vietti TJ, Miser JS. Addition of ifosfamide and etoposide to standard chemotherapy for Ewing's sarcoma and primitive neuroectodermal tumor of bone. N Engl J Med. 2003 Feb 20;348(8):694-701. doi: 10.1056/NEJMoa020890.
- Background: PubMed 9053480West DC, Grier HE, Swallow MM, Demetri GD, Granowetter L, Sklar J. Detection of circulating tumor cells in patients with Ewing's sarcoma and peripheral primitive neuroectodermal tumor. J Clin Oncol. 1997 Feb;15(2):583-8. doi: 10.1200/JCO.1997.15.2.583.
- Background: PubMed 7542227Pfleiderer C, Zoubek A, Gruber B, Kronberger M, Ambros PF, Lion T, Fink FM, Gadner H, Kovar H. Detection of tumour cells in peripheral blood and bone marrow from Ewing tumour patients by RT-PCR. Int J Cancer. 1995 Apr 21;64(2):135-9. doi: 10.1002/ijc.2910640211.
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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.
Crystal L Mackall, 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 Non-Metastatic Ewings Sarcoma, 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 1 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 17 Dec 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 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 NCT00339898, 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 17 Dec 2019.