Clinical trial NCT02790983: Primary Tumor Research and Outcomes Network
Official title: Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Column Tumor
Keywords: Registry
Spine
Surgery
Medical Oncology
Radiation Oncology
Neoplasms
Systemic Oncologic Therapy
Radiation Therapy
Tumor Markers
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2016-06-06
Enrollment: 1350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a primary tumor of the spine or patients with a history of a spine tumor

Brief summary: This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Detailed description: Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with:

* survival
* local recurrence
* morbidity data
* patient reported outcomes

Outcome measures: Variables applicable to primary spinal column tumor patients which will be collected in the registry include:

* Patient details
* Treatment status
* Details of previous treatment
* Diagnosis and biopsy types
* Tumor details
* Oncological staging
* Symptoms
* Treatment details
* Imaging information

We aim to collect the following outcome measures:

* Overall survival data
* Local disease recurrence data
* Morbidity data
* Patient reported outcomes:
* Euroquol-5D-3L, EQ-5D-Y (if applicable)
* Euroquol EQ-5D VAS - Quality of Life
* Neck pain numeric rating scale (NRS)
* Arm pain NRS
* Back pain NRS
* Leg Pain NRS
* SF-36 version 2
* SOSG Outcome Questionnaire (SOSGOQ) v1.0 and v2.0
* Surverys on patient expectations and satisfaction

Eligibility criteria: Inclusion criteria

* Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.).
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the registry according to the Registry Plan (RP)
  * Signed and dated EC/IRB approved written informed consent

OR

* Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria:

- Patient diagnosed with a metastatic tumor of the spine.

Primary outcomes:
measure: Overall survival data
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: Local disease recurrence data
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: Perioperative morbidity data
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
Secondary outcomes:
measure: Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y)
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: Pain Numeric Rating Scale
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: SF-36 version 2
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: Spine Oncology Study Group Outcome Questionnaire
timeFrame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years
measure: Survey on patient expectation
timeFrame: Prior to surgical treatment
measure: Survey on patient satisfaction
timeFrame: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Brisbane
country: Australia
facility: University of Queensland, School of Medicine
city: Vancouver
country: Canada
facility: Vancouver General Hospital and the University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders and Buda Health Center
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Kanazawa
country: Japan
facility: Kanazawa Medical University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
Study officials:
affiliation: Clinical Lead for Spinal Surgery at Oxford University Hospitals
name: Jeremy Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: