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Completed

NCT Number: NCT02948088

Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project

TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT.

This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

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Key information

Conditions

Giant Cell Tumors Giant Cell Tumor of Tendon Sheath Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Synovitis Synovitis, Pigmented Villonodular Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Graz, Graz, Austria

Loading trial locations.

About this study

GCT is a rare, benign, but potentially locally aggressive and recurrent disease. Treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient.

There will be no attempt to influence the prescribing patterns of any individual treating physician. All medication will be prescribed in the usual standard of care and will not be provided by the study sponsor.

Participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study.

It is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic Case Report Form (eCRF) and in the patients' medical records.

Approximately 15 sites from up to 6 European Countries (France, Germany, Italy, The Netherlands, Spain and United Kingdom) and 4 sites from the US are planned to participate. The sites will be specialized sites that treat d-TGCT regularly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent for participation in the study (ICF)
  • Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case

Exclusion criteria

  • As this is a non interventional study, no explicit exclusion criteria have been defined

Treatment and study plan

Primary outcomes

  1. Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.

  2. Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.

  3. Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.

  4. Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.

  5. Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.

  6. Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)

    Time frame: at Baseline

    Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments).

  7. Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)

    Time frame: at Baseline (prior to any d-TGCT therapy)

    Complications due to surgery were collected from information routinely recorded in the patient files / medical records.

  8. Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)

    Time frame: at Baseline

    Tumor recurrence was collected from information routinely recorded in the patient files / medical records.

  9. Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT)

    Time frame: at Baseline

    Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.

  10. Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT)

    Time frame: Baseline up to end of observation period (approximately 2 years)

    Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.

  11. Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome.

  12. Mean Worst Stiffness Score From Baseline Through 24 Months

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome.

  13. Mean PROMIS Physical Function Score From Baseline Through 24 Months

    Time frame: Baseline up to end of observation period (approximately 2 years)

    PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome.

Secondary outcomes

  1. Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months

    Time frame: Baseline up to end of observation period (approximately 2 years)

    The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome.

  2. Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months

    Time frame: 13-24 months before baseline up to end of observation period (approximately 2 years)

    Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported.

  3. Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months

    Time frame: 13-24 months before baseline up to end of observation period (approximately 2 years)

    The median number of days in rehabilitation and the number of work days missed were also reported.

  4. Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)

    Time frame: At end of observation period (approximately 2 years post-baseline)

    TGCT outcome status was collected from information routinely recorded in the patient files / medical records.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Optimapharm

Registry information

Official study title

A Disease Registry for Patients With Tenosynovial Giant Cell Tumors (TGCT), Also Known as Pigmented Villonodular Synovitis (PVNS) and Giant Cell Tumor of the Tendon Sheath (GCT-TS)

Acronym: TOP

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2016
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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