Giant Cell TumorsTOPNCT02948088
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
An observational study of Giant Cell Tumors, run by Daiichi Sankyo at 15 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Tumors
- How many people
- 183 participants
- Where
- 15 sitesin 8 countries
- Study dates
- 18 Nov 2016to 11 Mar 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolled patients with d-TGCT.
Who may be able to join
- Written informed consent for participation in the study (ICF)
- Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case
Who cannot join
- As this is a non interventional study, no explicit exclusion criteria have been defined
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
United States4 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California San Francisco
San Francisco, California, 94158
Italy2 sites
Istituto Ortopedico Rizzoli
Bologna, 40136
Istituto Nazionale Tumori-Foundazione IRCCS
Milan, 20133
Netherlands2 sites
Leiden University Medical Center
Leiden, 2333
Radboud universitair medisch centrum
Nijmegen, 6525 GA
Spain2 sites
Hospital Sant Pau
Barcelona, 08041
Hospital Universitario Virgen del Rocio
Seville, 41013
United Kingdom2 sites
The Royal Marsden Hospital
London, SW3 6JJ
Nuffield Orthopaedic Centre
Oxford, OX3 7LD
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Giant Cell Tumors
- Keywords
- Tenosynovial Giant Cell Tumors, Disease registry, Routine clinical practice, Real World Evidence
- Medical subject headings
- Giant Cell Tumors, Synovitis, Pigmented Villonodular
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)
Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)
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).
Measured: at Baseline
Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)
Complications due to surgery were collected from information routinely recorded in the patient files / medical records.
Measured: at Baseline (prior to any d-TGCT therapy)
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
Tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Measured: at Baseline
Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT)
Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Measured: at Baseline
Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT)
Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Measured: Baseline up to end of observation period (approximately 2 years)
Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months
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.
Measured: Baseline up to end of observation period (approximately 2 years)
Mean Worst Stiffness Score From Baseline Through 24 Months
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.
Measured: Baseline up to end of observation period (approximately 2 years)
Mean PROMIS Physical Function Score From Baseline Through 24 Months
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.
Measured: Baseline up to end of observation period (approximately 2 years)
Secondary outcomes (4)
Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months
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.
Measured: Baseline up to end of observation period (approximately 2 years)
Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months
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.
Measured: 13-24 months before baseline up to end of observation period (approximately 2 years)
Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months
The median number of days in rehabilitation and the number of work days missed were also reported.
Measured: 13-24 months before baseline up to end of observation period (approximately 2 years)
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TGCT outcome status was collected from information routinely recorded in the patient files / medical records.
Measured: At end of observation period (approximately 2 years post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start18 Nov 2016
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Giant Cell TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimapharm
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948088
- Sponsor's protocol ID
- DS-ONC-01-15-EU
- Acronym
- TOP
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2016
- Last updated
- 31 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Palmerini E, Healey JH, Bernthal NM, Bauer S, Schreuder H, Leithner A, Martin-Broto J, Gouin F, Lopez-Bastida J, Gelderblom H, Staals EL, Mercier F, Laeis P, Ye X, van de Sande M. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies. Oncologist. 2023 Jun 2;28(6):e425-e435. doi: 10.1093/oncolo/oyad011.
PubMed 36869793Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.
PubMed 33926503
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02948088
- Acronym / sponsor ID
- TOP / DS-ONC-01-15-EU
- Conditions
- Giant Cell Tumors
- Keywords
- Tenosynovial Giant Cell Tumors, Disease registry, Routine clinical practice, Real World Evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Optimapharm
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 31 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled patients with d-TGCT.
Key inclusion criteria (2 listed)
- Written informed consent for participation in the study (ICF)
- Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case
Key exclusion criteria (1 listed)
- As this is a non interventional study, no explicit exclusion criteria have been defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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)
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)
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)
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Time frame: At end of observation period (approximately 2 years post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36869793Palmerini E, Healey JH, Bernthal NM, Bauer S, Schreuder H, Leithner A, Martin-Broto J, Gouin F, Lopez-Bastida J, Gelderblom H, Staals EL, Mercier F, Laeis P, Ye X, van de Sande M. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies. Oncologist. 2023 Jun 2;28(6):e425-e435. doi: 10.1093/oncolo/oyad011.
- Derived from this study: PubMed 33926503Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Tumors, run by Daiichi Sankyo at 15 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Italy, Netherlands, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.