Soft Tissue SarcomaNCT05171413
Predictive Models of Treatment Responses and Survival Outcomes in Patients With Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma, run by West China Hospital at 1 site in China.
Trial summary
The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with soft tissue sarcoma and compared these models with currently available models. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Prediction model
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- 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: Patients with soft tissue sarcoma who were diagnosed histologically with definite pathologic specimens.
Who may be able to join
- Receiving no treatment before diagnosis
- With written informed consent
Who cannot join
- Clinical data missing
- Without written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 6100041
Yuhan Yang, MD, 8613258389785, yyh_1023@163.com
About this study
The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with soft tissue sarcoma and compared these models with currently available models.
Read the detailed description
We performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven soft tissue sarcoma. Secondly, we aimed to compare the predictive accuracy with currently available noninvasive model.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Prediction model
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction modelOther
We develop and validate clinical models to predict treatment responses and survival outcomes in patients with biopsy-proven with soft tissue sarcoma.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort. Receives: Other: Prediction model | |
| Prospective cohort | The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort. Receives: Other: Prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
The primary outcome was the evaluation of treatment response to individualized therapy in patients with soft tissue sarcoma.
Measured: At least 1-year follow up
Progression-free survival outcomes
The endpoint was defined as the occurrence of progression or recurrence, or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence, or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.
Measured: At least 5-year follow up
Overall survival outcomes
The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.
Measured: At least 5-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by West China 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
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhan Yang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171413
- Sponsor's protocol ID
- HX-20211156
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Models of Treatment Responses and Survival Outcomes in Patients With Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05171413
- Acronym / sponsor ID
- HX-20211156
- Conditions
- Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2021 (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.
The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with soft tissue sarcoma and compared these models with currently available models.
Detailed description
We performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven soft tissue sarcoma. Secondly, we aimed to compare the predictive accuracy with currently available noninvasive model.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: Prediction modelThe internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort. |
| Prospective cohort | – | Other: Prediction modelThe same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with soft tissue sarcoma who were diagnosed histologically with definite pathologic specimens.
Key inclusion criteria (2 listed)
- Receiving no treatment before diagnosis
- With written informed consent
Key exclusion criteria (2 listed)
- Clinical data missing
- Without written informed consent
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 |
|---|---|---|
| Prediction modelWe develop and validate clinical models to predict treatment responses and survival outcomes in patients with biopsy-proven with soft tissue sarcoma. | Other | Prospective cohort, Retrospective cohort |
Primary outcome
Treatment response
Time frame: At least 1-year follow up
The primary outcome was the evaluation of treatment response to individualized therapy in patients with soft tissue sarcoma.
Progression-free survival outcomes
Time frame: At least 5-year follow up
The endpoint was defined as the occurrence of progression or recurrence, or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence, or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.
Overall survival outcomes
Time frame: At least 5-year follow up
The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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.
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 Soft Tissue Sarcoma, run by West China 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 2 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 28 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuhan Yang, MD (8613258389785, yyh_1023@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: At least 1-year follow up). 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 28 Dec 2021.