NeuroblastomaNCT02558244
Impact of Image-defined Risk Factors on the Outcome of Patients With Neuroblastoma: A Retrospective Study
An observational study of Neuroblastoma, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of South Egypt Cancer Institute… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Oct 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric cancer patients, those diagnosed with Neuroblastoma, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Who may be able to join
- Patients whose age less than 19 years.
- Patients diagnosed with non-metastatic neruoblastoma.
Who cannot join
- Patients whose age more than 18 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Ahmed M. Morsy, MD, +2 01003314522, ahmedmohammed7829@yahoo.com
Ahmed M. Morsy, MD
About this study
The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in Upper Egypt.
Read the detailed description
Background:
Neuroblastoma is the third most common childhood cancer, after leukemia and brain tumors, and is the most common solid extracranial tumor in children.
The concept of surgical risk factors in neuroblastoma surgery was introduced with the European multicenter study (LNESG1) study.
In 2005 the International Neuroblastoma Risk Group (INRG) Task Force, representing all major co-operative pediatric cancer groups, adopted the principle of surgical risk factors and incorporated it in the INRG Staging System. The INRG Task Force preferred the term Image-Defined Risk Factors (IDRF) to surgical risk factors, and agreed upon a list of IDRF.
Patients \& Methods:
This retrospective study will be carried out by reviewing the medical records of patients with neuroblastoma seen at the pediatric oncology department, in the period from 2001 January till 2015 December.
Data from Patients' medical records will be gathered, Pathologic diagnosis of neuroblastoma will be verified before the enrollment into the study. As an initial imaging was done for all patients at presentation, as a routine for diagnosis \& staging, the reports of the computed tomography scans will be reviewed for verification of the presence or absence of the IDRF. This historical cohort will be followed forward with time for ascertainment of the role of surgery in treatment, and treatment outcomes of these patients. Any complications occurred due to surgery will be reported, as collected from surgical reports of these patients.
- Conditions
- Neuroblastoma
- Keywords
- Childhood Cancer, Image-defined Risk Factors, Pediatric Oncology
- Medical subject headings
- Neuroblastoma, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from the date of diagnosis until death from any cause
Measured: Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years
Event Free Survival (EFS)
Time from the date of diagnosis until disease progression, or death for any reason.
Measured: Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years
Secondary outcomes (1)
Complications of Surgery
Measured: Participants will be retrospectively followed forward in time from the date of surgical operation till the occurence of any complication due to surgery, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
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 NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Morsy, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558244
- Sponsor's protocol ID
- Image-defined RF NB
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2015
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Cecchetto G, Mosseri V, De Bernardi B, Helardot P, Monclair T, Costa E, Horcher E, Neuenschwander S, Toma P, Rizzo A, Michon J, Holmes K. Surgical risk factors in primary surgery for localized neuroblastoma: the LNESG1 study of the European International Society of Pediatric Oncology Neuroblastoma Group. J Clin Oncol. 2005 Nov 20;23(33):8483-9. doi: 10.1200/JCO.2005.02.4661.
PubMed 16293878Monclair T, Brodeur GM, Ambros PF, Brisse HJ, Cecchetto G, Holmes K, Kaneko M, London WB, Matthay KK, Nuchtern JG, von Schweinitz D, Simon T, Cohn SL, Pearson AD; INRG Task Force. The International Neuroblastoma Risk Group (INRG) staging system: an INRG Task Force report. J Clin Oncol. 2009 Jan 10;27(2):298-303. doi: 10.1200/JCO.2008.16.6876. Epub 2008 Dec 1.
PubMed 19047290Brisse HJ, McCarville MB, Granata C, Krug KB, Wootton-Gorges SL, Kanegawa K, Giammarile F, Schmidt M, Shulkin BL, Matthay KK, Lewington VJ, Sarnacki S, Hero B, Kaneko M, London WB, Pearson AD, Cohn SL, Monclair T; International Neuroblastoma Risk Group Project. Guidelines for imaging and staging of neuroblastic tumors: consensus report from the International Neuroblastoma Risk Group Project. Radiology. 2011 Oct;261(1):243-57. doi: 10.1148/radiol.11101352. Epub 2011 May 17.
PubMed 21586679
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Image-defined Risk Factors on the Outcome of Patients With Neuroblastoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02558244
- Acronym / sponsor ID
- Image-defined RF NB
- Conditions
- Neuroblastoma
- Keywords
- Childhood Cancer, Image-defined Risk Factors, Pediatric Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Sep 2015 (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 aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in Upper Egypt.
Detailed description
Background:
Neuroblastoma is the third most common childhood cancer, after leukemia and brain tumors, and is the most common solid extracranial tumor in children.
The concept of surgical risk factors in neuroblastoma surgery was introduced with the European multicenter study (LNESG1) study.
In 2005 the International Neuroblastoma Risk Group (INRG) Task Force, representing all major co-operative pediatric cancer groups, adopted the principle of surgical risk factors and incorporated it in the INRG Staging System. The INRG Task Force preferred the term Image-Defined Risk Factors (IDRF) to surgical risk factors, and agreed upon a list of IDRF.
Patients \& Methods:
This retrospective study will be carried out by reviewing the medical records of patients with neuroblastoma seen at the pediatric oncology department, in the period from 2001 January till 2015 December.
Data from Patients' medical records will be gathered, Pathologic diagnosis of neuroblastoma will be verified before the enrollment into the study. As an initial imaging was done for all patients at presentation, as a routine for diagnosis \& staging, the reports of the computed tomography scans will be reviewed for verification of the presence or absence of the IDRF. This historical cohort will be followed forward with time for ascertainment of the role of surgery in treatment, and treatment outcomes of these patients. Any complications occurred due to surgery will be reported, as collected from surgical reports of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric cancer patients, those diagnosed with Neuroblastoma, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Key inclusion criteria (2 listed)
- Patients whose age less than 19 years.
- Patients diagnosed with non-metastatic neruoblastoma.
Key exclusion criteria (1 listed)
- Patients whose age more than 18 years.
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
Overall survival (OS)
Time frame: Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years
Time from the date of diagnosis until death from any cause
Event Free Survival (EFS)
Time frame: Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years
Time from the date of diagnosis until disease progression, or death for any reason.
1 secondary outcome
Complications of Surgery
Time frame: Participants will be retrospectively followed forward in time from the date of surgical operation till the occurence of any complication due to surgery, an expected average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 16293878Cecchetto G, Mosseri V, De Bernardi B, Helardot P, Monclair T, Costa E, Horcher E, Neuenschwander S, Toma P, Rizzo A, Michon J, Holmes K. Surgical risk factors in primary surgery for localized neuroblastoma: the LNESG1 study of the European International Society of Pediatric Oncology Neuroblastoma Group. J Clin Oncol. 2005 Nov 20;23(33):8483-9. doi: 10.1200/JCO.2005.02.4661.
- Background: PubMed 19047290Monclair T, Brodeur GM, Ambros PF, Brisse HJ, Cecchetto G, Holmes K, Kaneko M, London WB, Matthay KK, Nuchtern JG, von Schweinitz D, Simon T, Cohn SL, Pearson AD; INRG Task Force. The International Neuroblastoma Risk Group (INRG) staging system: an INRG Task Force report. J Clin Oncol. 2009 Jan 10;27(2):298-303. doi: 10.1200/JCO.2008.16.6876. Epub 2008 Dec 1.
- Background: PubMed 21586679Brisse HJ, McCarville MB, Granata C, Krug KB, Wootton-Gorges SL, Kanegawa K, Giammarile F, Schmidt M, Shulkin BL, Matthay KK, Lewington VJ, Sarnacki S, Hero B, Kaneko M, London WB, Pearson AD, Cohn SL, Monclair T; International Neuroblastoma Risk Group Project. Guidelines for imaging and staging of neuroblastic tumors: consensus report from the International Neuroblastoma Risk Group Project. Radiology. 2011 Oct;261(1):243-57. doi: 10.1148/radiol.11101352. Epub 2011 May 17.
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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.
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 Neuroblastoma, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Participants will be retrospectively followed forward in time from the date of diagnosis till the primary completion date of the study, an expected average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558244, 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 24 Jul 2023.