Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03141021 |
|
Recruitment Status :
Recruiting
First Posted : May 4, 2017
Last Update Posted : November 21, 2023
|
Sponsor:
Washington University School of Medicine
Collaborator:
Boston's Children Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 13, 2017 | ||||
| First Posted Date | May 4, 2017 | ||||
| Last Update Posted Date | November 21, 2023 | ||||
| Actual Study Start Date | April 28, 2017 | ||||
| Estimated Primary Completion Date | April 30, 2053 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors | ||||
| Official Title | Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors | ||||
| Brief Summary | First, the investigators plan to use a retrospective analysis to determine the clinical landscape of neurofibromatosis (NF)1-associated malignant peripheral nerve sheath tumor (MPNST) and precursor lesions (e.g., atypical or nodular plexiform neurofibromas). A worldwide database will be established, collecting, in a standardized manner, histologic, immunohistochemical, molecular, radiographic, treatment, and related clinical data from centers worldwide with expertise in these NF1-related cancers. Although retrospective in nature, the resulting data from this registry may reveal previously unanticipated patterns, similar to the INFACT effort outcome. This registry would then allow the acquisition of data associated with MPNST biospecimens collected under associated banks (frozen or paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic whole-exome or whole-genome sequencing data for aggregate analyses). Second, the investigators plan to co-register patients to institutional banks in order to prospectively collect MPNST samples for analysis. These patients will be consented in order to collect the above information and for banking of tumor tissue and future studies that include genomic characterization of the tumors. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
||||
| Target Follow-Up Duration | 10 Years | ||||
| Biospecimen | Retention: Samples With DNA Description: Biospecimens collected under associated banks (frozen or paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic whole-exome or whole-genome sequencing data for aggregate analyses) and prospectively collect MPNST samples for analysis.
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The oncology clinic of each participating institution | ||||
| Condition | Malignant Peripheral Nerve Sheath Tumors | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
1050 | ||||
| Original Estimated Enrollment |
1000 | ||||
| Estimated Study Completion Date | April 30, 2053 | ||||
| Estimated Primary Completion Date | April 30, 2053 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria and Exclusion Criteria: -Any patient diagnosed with an MPNST is eligible for enrollment to this registry provided s/he consents to participate (or consent form his/her parent or legal guardian is obtained). |
||||
| Sex/Gender |
|
||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| Listed Location Countries | Canada, India, United Kingdom, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03141021 | ||||
| Other Study ID Numbers | 201702006 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Current Responsible Party | Washington University School of Medicine | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | Washington University School of Medicine | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Boston's Children Hospital | ||||
| Investigators |
|
||||
| PRS Account | Washington University School of Medicine | ||||
| Verification Date | November 2023 | ||||