Bone and Soft Tissue TumorsNCT05468970
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors
An observational study of Bone and Soft Tissue Tumors and Clinical Features, run by Henan Cancer Hospital at 1 site in China.
Trial summary
It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and… Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Bone and Soft Tissue Tumors, Clinical Features
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 31 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with bone and soft tissue tumors receiving inpatient treatment in Henan Tumor Hospital.
Who may be able to join
- All ages, male and female.
- The pathological diagnosis of BSTS in our hospital was a subtype.
- Has received at least one hospitalization in this hospital.
- The target lesions could be evaluated according to the efficacy evaluation criteria of solid tumor (RECIST; Version 1.1) Measure diameter changes.
Who cannot join
- No definite pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zhichao Tian, Dr., +8618737187831, tianzhichhaoyy@163.com
About this study
Official title: Single-center Real World Prospective Observational Study of Clinical Features, Treatment Patterns, and Survival of Bone and Soft Tissue Tumors
It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor.
Read the detailed description
It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.
- Conditions
- Bone and Soft Tissue Tumors, Clinical Features
- Being tested
- NO Intervention
- Medical subject headings
- Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO InterventionOther
NO Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Pathologically confirmed events leading to death
Measured: Up to approximately 120months
6/5000 Progression-free survival
The time from the first use of the treatment to the observation of disease progression
Measured: Up to approximately 48months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start3 Aug 2022
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Soft Tissue TumorsStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468970
- Sponsor's protocol ID
- ZZUSC-12
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2022
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Real World Prospective Observational Study of Clinical Features, Treatment Patterns, and Survival of Bone and Soft Tissue Tumors
- ClinicalTrials.gov ID
- NCT05468970
- Acronym / sponsor ID
- ZZUSC-12
- Conditions
- Bone and Soft Tissue Tumors, Clinical Features
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 21 Jul 2022 (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.
It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor.
Detailed description
It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with bone and soft tissue tumors receiving inpatient treatment in Henan Tumor Hospital.
Key inclusion criteria (4 listed)
- All ages, male and female.
- The pathological diagnosis of BSTS in our hospital was a subtype.
- Has received at least one hospitalization in this hospital.
- The target lesions could be evaluated according to the efficacy evaluation criteria of solid tumor (RECIST; Version 1.1) Measure diameter changes.
Key exclusion criteria (1 listed)
- No definite pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO InterventionNO Intervention | Other | – |
Primary outcome
Overall survival
Time frame: Up to approximately 120months
Pathologically confirmed events leading to death
6/5000 Progression-free survival
Time frame: Up to approximately 48months
The time from the first use of the treatment to the observation of disease progression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bone and Soft Tissue Tumors
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Soft Tissue Tumors and Clinical Features, run by Henan Cancer Hospital at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Jiaqiang, Dr. (13592413731, wjqwtj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to approximately 120months). The study lists 2 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 1 Sep 2023.