SensitivityCESOFBNCT03358992
Clinical Evaluation for Sarcoma Originated From Bone
An observational study of Sensitivity and Specificity, run by Peking University People's Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sensitivity, Specificity, Histological Response
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2018to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.
Who may be able to join
- 1) histologically confirmed high-grade osteosarcoma;
- 2) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
- 3) imaging evaluation should be available;
- 4) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
- 5) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
- 6) acceptable hematologic, hepatic, and renal function.
Who cannot join
- 1) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
- 2) lost to follow-up.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, 100044
Tingting Ren, Ph.D., +86-13810095026, tumorcenter@163.com
- Recruiting
The second affliated Hospital of Zhejiang University School of medicine
Hangzhou, Zhejiang
Zhaoming Ye, M.D., +8613606501549, yezhaominghz@163.com
Zhaoming Ye, M.D.
- Recruiting
Xijing Hospital
Xi'an
Zhen Wang, M.D., +8613909298882, wangzhen@fmmu.edu.cn
Zhen Wang, M.D.
About this study
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.
Read the detailed description
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.
- Conditions
- Sensitivity, Specificity, Histological Response, Survival
- Keywords
- CESOFB, clinical evaluation, RECIST, histological response, survival, osteosarcoma, Ewing sarcoma
- Medical subject headings
- Hypersensitivity, Osteosarcoma, Sarcoma, Ewing
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.
Measured: 12 months
Specificity
Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.
Measured: 12 months
Pathological response rate
tumor necrosis rate descripted by Huvos
Measured: 12 months
Secondary outcomes (2)
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
Measured: 24 months
overall survival
overall survival is defined as time from diagnosis to death from any cause.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jan 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitivityStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Guo, Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358992
- Sponsor's protocol ID
- CBTRA-01
- Acronym
- CESOFB
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation for Sarcoma Originated From Bone
- ClinicalTrials.gov ID
- NCT03358992
- Acronym / sponsor ID
- CESOFB / CBTRA-01
- Conditions
- Sensitivity, Specificity, Histological Response, Survival
- Keywords
- CESOFB, clinical evaluation, RECIST, histological response, survival, osteosarcoma, Ewing sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Xijing Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.
Key inclusion criteria (6 listed)
- 1) histologically confirmed high-grade osteosarcoma;
- 2) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital, Xijing Hospital or The Second Hospital affiliated to Zhejiang Hospital;
- 3) imaging evaluation should be available;
- 4) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
- 5) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
Key exclusion criteria (2 listed)
- 1) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
- 2) lost to follow-up.
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
Sensitivity
Time frame: 12 months
Sensitivity is defined as the true right clinical evaluated number/ the pathological evaluated number by different classification system.
Specificity
Time frame: 12 months
Specificity is defined as the true wrong clincial evuluated number /the pathological evaluated number by different classification system.
Pathological response rate
Time frame: 12 months
tumor necrosis rate descripted by Huvos
2 secondary outcomes
progression-free survival
Time frame: 24 months
overall survival
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Wei Guo principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensitivity and Specificity, run by Peking University People's Hospital at 3 sites in China.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (+86-13401044719, sweetdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2018.