Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)

NCT02559804 | Recruiting

• 1 other identifier: NB with SCI
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To describe the natural history of peripheral neuroblastic tumour presenting with SCI and evaluate the combined effects of different risk factors on the eventual neurologic and orthopaedic outcomes

Conditions

Neuroblastic Tumors

Outcome Measures

Primary Outcomes (3)

• prevalence of neurologic consequences

  American Spinal Injury Association ASIA impairment scale

  for 5 years

• prevalence of orthopedic consequences

  using Common Terminology Criteria for Adverse Events v. 4.0

  for 5 years

• prevalence of pain

  using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)

  for 5 years

Secondary Outcomes (2)

• relapse or second tumour

  5 years

• survival

  5 years

Study Arms (1)

patients NB with SCI

Survival and late effects. Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression).

Other: survival and late effects

Interventions

survival and late effects OTHER

survival and late effects

patients NB with SCI

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients in the age range 0-18 years diagnosed with peripheral neuroblastic tumour and SCI in the period from May 2014 to April 2017

You may qualify if:

• Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression)
• No previous chemotherapy, except steroids, in the last 6 months
• Age \<18 years
• Minimal planned follow-up of 5 years
• Parent/patient written informed consent (Appendix 1(A,B,C))

You may not qualify if:

• Invasion of intervertebral foramina only

Sponsors & Collaborators

• Associazione Italiana Ematologia Oncologia Pediatrica: lead
• Istituto Giannina Gaslini: collaborator

Study Sites (1)

Istituto Giannina Gaslini

Genova, 16147, Italy

RECRUITING

Study Officials

• Riccardo Haupt, MD

  Istituto Giannina Gaslini Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Haupt, MD

CONTACT

01056363462; riccardohaupt@ospedale-gaslini.ge.it

tiziana landi

CONTACT

051/2144667; segreteria@aieop.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 24, 2015
• Study Start: May 1, 2014
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

IT (1)