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Primary Tumor Research and Outcomes Network (PTRON)

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: NCT02790983
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
AO Foundation, AO Spine
Information provided by (Responsible Party):
AO Innovation Translation Center

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.

Condition or disease
Spinal Column Tumor

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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 Start Date : October 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023



Primary Outcome Measures :
  1. Overall survival data [ Time Frame: 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 ]
    FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive

  2. Local disease recurrence data [ Time Frame: 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 ]
    At first prospective treatment and every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease recurrence. Patients that are classified as "non-virgin" will be evaluated for local disease recurrence also at baseline.

  3. Perioperative morbidity data [ Time Frame: 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 ]

    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: 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 ]

    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: 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 ]
    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: 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 ]
    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: 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 ]
    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 20 items representing all four domains of the International Classification of Function and Disability. Additionally, there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health, and social function. During the first phase of this registry, patients completed the SOSGOQ version 1.0. The English SOSGOQ version 2.0 was released in January 2018 and will be used

  5. Survey on patient expectation [ Time Frame: Prior to surgical treatment ]
    A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.

  6. Survey on patient satisfaction [ Time Frame: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years ]
    A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.


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 or patients with a history of a spine tumor
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.


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
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Contact: Severine Bender, Dr. +41 78 634 19 82 severine.bender@aofoundation.org

Locations
Show Show 19 study locations
Sponsors and Collaborators
AO Innovation Translation Center
AO Foundation, AO Spine
Investigators
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Principal Investigator: Jeremy Reynolds, MD Clinical Lead for Spinal Surgery at Oxford University Hospitals
Additional Information:

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Responsible Party: AO Innovation Translation Center
ClinicalTrials.gov Identifier: NCT02790983    
Other Study ID Numbers: PTRON
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Innovation Translation Center:
Registry
Spine
Surgery
Medical Oncology
Radiation Oncology
Neoplasms
Systemic Oncologic Therapy
Radiation Therapy
Tumor Markers
Additional relevant MeSH terms:
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Neoplasms