An observational study in Sensitivity, Specificity and Histological Response, sponsored by Peking University People's Hospital. Status unknown at 3 sites in China. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Peking University People's Hospital · Observational
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Among 33 studies in Hypersensitivity with a site in China — 8 open to participants now, 8 under way, none of them phase 3. Hypersensitivity · China.
Among the 33 studies in Hypersensitivity with a site in China, this one is the 5th largest by planned enrollment of the 15 observational ones that give a count, is one of 4 that started in 2018, is one of 15 observational ones, and was the 10th registered.
1,056 studies on the registry are indexed under Hypersensitivity; 150 are open to participants now.
Browse Hypersensitivity studies →8 of the 33 studies in Hypersensitivity with a site in China are open now. Recruiting first, the newest first:
Qifeng Zhang · Sites in China, United States
Children's Hospital of Fudan University · Sites in China
Ages 1–18
Bo Wang,MD · Sites in China
Ages 18+
Min-Tze LIONG · Sites in China, Malaysia
Ages 0 mo–36 mo · Healthy volunteers
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 14–90
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 101 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 52 (51%) stop at 75 or younger; 56 take children under 18; 37 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 166 across 328 observational studies indexed under Hypersensitivity.
Median enrollment 169 across the 18 interventional studies, 180 across the 15 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 33 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
Peking University People's Hospital has 1 study filed under Hypersensitivity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 33 studies in Hypersensitivity with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.
A total of 1570 lesions were evaluated by clinical imaging including X-ray, computed tomography, magnetic resonance imaging and bone scan or PET/CT preoperatively treated with chemotherapy. All patients had surgery in our center and get pathological evaluation by tumor necrosis rate. Statistical diversity analysis was performed by different pathological groups and Receiver Operating Characteristic Curves，ROC were done to find the dividing clinical parameters (Cut-off values) to distinguish different pathological groups.The cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for Huvos Ⅳ,Ⅲ,ⅡandⅠgroups. The differentiation was not obvious using bone scan to distinguish different pathological responses. And the cut-off value for SUVmax value for Huvos Ⅲ,ⅡandⅠgroups were 60.7% and 31.4%.After Multidisciplinary discussion in multiple sites of China, we finally designed a evaluation system based on our data. This study is desgined to prospectively compare the sensitivity and specificity of this Clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as RECIST 1.1, Choi and PERCIST.
Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sensitivity
Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.
Time frame: 12 months
Specificity
Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.
Time frame: 12 months
Pathological response rate
tumor necrosis rate descripted by Huvos
Time frame: 12 months
progression-free survival
Progression-free survival is defined as time from diagnosis to the first occurrence of progression of disease or death from any cause
Time frame: 24 months
overall survival
overall survival is defined as time from diagnosis to death from any cause.
Time frame: 60 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Dec 2018, 11 months after the start.
Of 102 non-industry observational studies under Hypersensitivity, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 203. This study's planned 11 months is below that.
Counting every sponsor, half of 125 studies reached it within 41 months; a quarter within 19 and three quarters within 136.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital →