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Primary Tumor Research and Outcome Network (PTRON)

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ClinicalTrials.gov Identifier: NCT02790983
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:
Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients will be collected and evaluated to investigate the prognostic factors which influence survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups of patients diagnosed with primary spinal column tumors.

Condition or disease
Spinal Column Tumor

Detailed Description:

Objective: To prospectively investigate the prognostic variables (clinical, diagnostic, and therapeutic) within subgroups of patients diagnosed with primary spinal column tumors that are associated with:

  • survival
  • local recurrence
  • perioperative morbidity
  • 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

The investigators aim to collect the following outcome measures:

  • Overall survival data
  • Local disease recurrence data
  • Perioperative morbidity data

Patient reported outcomes:

  • Euroqual-5D-3L
  • 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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Primary Tumor Research and Outcome Network (PTRON) A Multicenter Prospective Registry for the Management of Primary Tumors of the Spine
Study Start Date : October 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019



Primary Outcome Measures :
  1. Overall survival data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]

    For every follow-up visit, each patient will be assessed in terms of their survival status. If death is known, no further action is required. If the patient's status is "alive" and the last follow-up visit is older than 3 months, a cross-sectional assessment of the current status will be performed for the follow-up visit.

    Cross-sectional survival data: Patients whose status at last follow-up was classified as "alive" will be included in the cross-sectional data collection set. This procedure should ensure that vital status data of all patients are complete and updated in order to perform a valid overall survival analysis. Medical charts will be the primary source used to determine the current vital status of the study patients. If the participating investigational sites have access to individual patient data through an official vital statistics, they may revert to this option or by contacting the patient's family doctor, the patient, or the patient's relatives.


  2. Local disease recurrence data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    For every follow-up visit, each patient, regardless of which stage they are at in their treatment will be evaluated for local disease recurrence. Presence or absence of a local recurrence and distant metastases should be confirmed through imaging. The analysis will be performed in accordance with local standard of care scheduled follow-up visits.

  3. Perioperative morbidity data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]

    Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up.

    Intraoperative complications: (Airway/ventilation; Allergic reaction; Anesthesia related; Bone implant interface failure requiring revision; Cardiac; Cord injury; Dural tear; Hardware malposition requiring revision; Hypotension ; Massive blood loss ; Nerve root injury; Pressure sores; Vascular injury; Visceral injury; Other).

    Pre-/post treatment complications: (Cardiac arrest/failure/arrhythmia; Construct failure with loss of correction; Construct failure without loss of correction; CSF leak/meningocele; Deep vein thrombosis; Deep wound infection; Delirium; Dysphagia; Dysphonia; GI bleeding; Hematoma; Myocardial infarction; Neurologic deterioration; Non-union; Pneumonia; Postoperative neuropathic pain; Pressure sores; Pulmonary embolism; Superficial wound infection; Systemic infection; Urinary tract infection; Wound dehiscence; Other)



Secondary Outcome Measures :
  1. Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]

    The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status.

    EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.


  2. Pain Numeric Rating Scale [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    It will be assessed for neck, back, leg and arm. The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

  3. SF-36 version 2 [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS). A scoring algorithm is available using linear T-score transformation that translates scores using population based norms into scores with mean = 50 and standard deviation = 10. The algorithm is available for all 8 subscales as well for the PCS and MCS.

  4. Spine Oncology Study Group Outcome Questionnaire [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
    This is a new HRQOL outcome tool which was developed specifically for metastatic spine disease. It is currently available in English and Hungarian. It contains 56 concepts representing all four domains of the International Classification of Function and Disability. It is made up of five domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors.


Biospecimen Retention:   Samples Without DNA
Tumor tissue and adjacent normal tissue Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with a primary tumor of the spine who receive medical and/or surgical treatment.
Criteria

Inclusion Criteria:

  • Patient diagnosed with a primary tumor of the spine who receive medical and/or surgical treatment for the tumor.
  • Patient willing and able to participate in the registry and able to attend follow-up visits, according to the investigator.
  • Patient capable of understanding the content of the patient information and Informed Consent Form (if consent is required by the EC/ IRB at the registry site).
  • Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

Exclusion Criteria:

  • Patient diagnosed with a metastatic tumor of the spine.
  • Patient diagnosed with a primary spinal cord tumor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790983


Contacts
Contact: Daniela Voegtli +41 81 414 25 10 daniela.voegtli@aofoundation.org
Contact: Severine Hurni, Dr. +41 81 414 25 09 severine.hurni@aofoundation.org

Locations
United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, CA 94134
Contact: Dean Chou, MD       Dean.Chou@ucsf.edu   
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, MD 21205
Contact: Chetan Bettegowda, MD       cbetteg1@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: John H Shin, MD       Shin.John@mgh.harvard.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michelle Clarke, MD       Clarke.Michelle@mayo.edu   
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, NY 10065
Contact: Mark Bilsky       bilskym@MSKCC.ORG   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Ziya L. Gokaslan, MD       ziya_gokaslan@brown.edu   
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Laurence D. Rhines, MD       lrhines@mdanderson.org   
Australia
University of Queensland, School of Medicine Suspended
Brisbane, Australia, 4000 QLD
Canada, British Columbia
Vancouver General Hospital and the University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Charles G. Fisher, Prof       charles.fisher@vch.ca   
Principal Investigator: Charles G. Fisher, Prof         
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Yoga Raja Rampersaud, MD, PhD    416-603-5627    raja.rampersaud@uhn.on.ca   
China, Beijing
Peking University 3rd Hospital Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Feng Wei, MD       mountweifeng@126.com   
Germany
Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden Recruiting
Dresden, Germany, 1307
Contact: Alexander Disch, PD, MD       alexander.disch@uniklinikum-dresden.de   
Hungary
National Center for Spinal Disorders and Buda Health Center Recruiting
Budapest, Hungary, 1126
Contact: Peter Paul Varga, MD       vpp@bhc.hu   
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Alessandro Gasbarrini, MD       gasbarrini@me.com   
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milano, Italy, 20161
Contact: Alessandro Luzzati, MD       alessandroluzzati@gmail.com   
Japan
Kanazawa Medical University Hospital Recruiting
Kanazawa, Japan, 920-8641
Contact: Norio Kawahara, MD, PhD       kawa@kanazawa-med.ac.jp   
United Kingdom
Oxford University Hospitals Recruiting
Oxford, United Kingdom, OX3 7HE
Contact: Jeremy Reynolds       jezreynolds@doctors.org.uk   
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine International
Investigators
Principal Investigator: Charles G. Fisher, MD Professor and Head

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02790983     History of Changes
Other Study ID Numbers: PTRON
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AO Clinical Investigation and Documentation:
Registry
Spine
Surgery
Medical Oncology
Radiation Oncology
Neoplasms