Trial · NCT00499616
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Rates | 3 years | OS time is calculated from date of enrollment until death, or until last contact if the patient is alive. |
| Primary | Definitive Determination of the Prognostic Ability of 1p and 11q | At baseline | Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q. |
| Primary | Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961 | Up to 3 years | Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age. |
| Primary | Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961 | Up to 3 years | Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age |
| Primary | Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma | Up to 3 years | Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event. |
| Primary | Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment | From baseline to up to 10 years | Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS) | Up to 10 years | To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates | Up to 10 years | To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. |
| Primary | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate | Up to 10 years | To test for the association of the extent of surgical resection (CR vs \<CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed. |
| Secondary | Second-event-free Survival (E2FS) | From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death; up to 3 years | E2FS (from time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy. |
| Secondary | Second-Overall Survival | From the time of the first progressive, non-metastatic event; up to 3 years | OS (from the time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy. |
| Secondary | Biological Surrogate Markers | At baseline and surgery | Multivariable analyses will be performed to identify variables of prognostic interest. |
| Secondary | Neurologic Symptoms | At baseline | Percentage of patients with neurologic symptoms will be calculated. Includes patients with paraspinal or intraspinal tumors, including epidural tumors with or without spinal cord compression. Neurologic symptoms include back or extremities neurologic symptoms, motor deficit, abnormal sensation, abnormal bladder/bowel sphincteric function, chronic pain in back or extremities, scoliosis, kyphosis, or clinically relevant/functional abnormality in size or contour of leg or foot. |
| Secondary | Association Between Surgical Biopsy Technique With Adequacy of Tissue Acquisition for Biologic Studies, and With Complications Associated With the Biopsy Procedure | During and after surgery | A chi-square test will be performed. |
| Secondary | Image Defined Risk Factor (IDRF) | At baseline | Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00499616/registered