An observational study in Giant Cell Tumor of Bone, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Peking University People's Hospital · Observational
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This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.All the patients enrolled will take denosumab according to the protocols.We focus on the recurrence rate after the drug withdrawl and possibility of malignant transformation.
This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.
This study only included patients who meet all the following criteria: (1) With treatment-naïve sacral giant-cell tumor (GCT) firstly treated in our center (for referral patients, only those with definite diagnosis were included); (2) Being diagnosed with classic giant-cell tumor of bone (GCTB) by puncture pathology prior to treatment (for referral patients, definite diagnosis shall be made by the Pathology Department in our center through pathology consultation on tissue sections); (3) previously denosumab-naïve.
Data collection:The following data of patients included in this study were collected: (1) basic information: age, gender; (2) pathological data: puncture pathological diagnosis, and postoperative pathological findings; (3) the imaging findings (including X-ray, CT, Magnetic resonance(MR), Positron Emission Tomography-Computed Tomography(PET-CT)) and functional assessment of patients in the neoadjuvant denosumab group before and after the use of denosumab; (4) intraoperative blood loss, and duration of operation; (5) imaging findings in postoperative follow-up re-examination and outcome.
functional assessment: For sacral giant cell tumor:The Motor Urination defecation(MUD) scoring system published on Spine by our center in 2016 , which include three domains (motor function and sensation of lower limbs [M], urination and uriesthesia [U], and Defecation and rectal sensation [D]) with three items in each domain (each item can be scored by 0, 1, 2 or 3, and the maximum score is 27), was applied in the functional assessment of sacral nerves.
For GCT occurs in Limbs ,we use Musculoskeletal Tumor Society (MSTS) 93 to record the function.
All the patients enrolled will take denosumab according to the protocols:denosumab 120mg was administrated to patients by subcutaneous injection every four weeks, with loading doses on Day 8 and Day 15 of the first cycle,them take it monthly till 1 year after the surgery.We focus on the recurrence rate after the drug withdrawl and possibility of malignant transformation.
23 studies on the registry are indexed under Giant Cell Tumor of Bone; 7 are open to participants now.
Browse Giant Cell Tumor of Bone studies →Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
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Patients with giant cell tumor of bone referred to, or being treated at Peking University People's Hostpital.
Inclusion Criteria:
(1) With treatment-naïve sacral GCT firstly treated in our center (for referral patients, only those with definite diagnosis were included); (2)single center lesion (3) Being diagnosed with classic GCTB by puncture pathology prior to treatment (for referral patients, definite diagnosis shall be made by the Pathology Department in our center through pathology consultation on tissue sections); (4) previously denosumab-naïve.
Exclusion Criteria:(1)primary malignant giant cell tumor of bone(2)radiation therapy in history(3)lung at first diagnosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the postoperative denosumab group, including patients receiving denosumab after piecemeal intralesional curettage aided by digital subtraction angiography(DSA) and balloon occlusion of abdominal aorta;
Drug: Denosumab
Denosumab 120mg was administrated to patients by subcutaneous injection every four weeks, with loading doses on Day 8 and Day 15 of the first cycle.Patients were instructed to take calcium supplements orally every day and avoid any oral operation during treatment
Also known as: XGEVA
recurrence without metastasis
CT or MR proof that the tumor relapse in the primary site by at least two radiologist
Time frame: up to 2 years
metastasis without recurrence
confirmed via lung CT scan by at least two radiologist
Time frame: up to 2 years
death from other disease
patient die from another disease but must not from giant cell tumor
Time frame: up to 2 years
death from giant cell tumor
patient die from the tumor itself
Time frame: up to 2 years
No study locations are listed for this record.
Plan to share: No
Start is estimated for Mar 2018; primary completion for Dec 2020, 33 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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