Soft Tissue SarcomaSarcomaPDXNCT02910895
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
A study testing tumor biopsy in people with Soft Tissue Sarcoma and Xenograft Model, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Xenograft Model, 2D/3D Cell Cultures
- What is being tested?
- tumor biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Sep 2017to Sep 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS
- Local recurrences are allowed
- Age ≥ 18 years
- Able and willing to undergo tumour biopsies or tumour sampling during surgery
- Localization of sarcoma enables safe biopsy or surgery
- Written informed consent
Who cannot join
- Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, 1066CX
Rick Haas, MD, PhD, +31 20 512 9111, r.haas@nki.nl
Astrid Scholten, MD, PhD, +31 20 512 9111, a.scholten@nki.nl
About this study
Official title: Development of a Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS): Protocol to Obtain Tumour Material From Patients With STS.
Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease.
The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.
- Conditions
- Soft Tissue Sarcoma, Xenograft Model, 2D/3D Cell Cultures
- Being tested
- tumor biopsy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor biopsyOther
biopsy
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | single tumor biopsy Receives: Other: tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas
take rate
Measured: 4 months
The take-rate of fresh human PDX tumour material in nude mice.
take rate
Measured: 4 months
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)
take rate
Measured: 2 years after start of study
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.
take rate
Measured: 6 weeks
A model for translational research
take rate
Measured: 2 years after start of study
Secondary outcomes (3)
The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice
take rate of continuous growth of implantation of tumor material
Measured: 4 months after implantation of tumour material
Fractionation sensitivity on several STS subtypes in PDX.
take rate
Measured: 4 months
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing
take rate of continuous growth
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start9 Sep 2017
- Primary completionSep 2024 (estimated)
- Study completionSep 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 The Netherlands Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Rick Haas, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910895
- Sponsor's protocol ID
- N16STS
- Other IDs
- NL58626.031.16
- Acronym
- SarcomaPDX
- Status last verified
- Jun 2024
- First submitted
- 21 Jul 2016
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS): Protocol to Obtain Tumour Material From Patients With STS.
- ClinicalTrials.gov ID
- NCT02910895
- Acronym / sponsor ID
- SarcomaPDX / N16STS
- Conditions
- Soft Tissue Sarcoma, Xenograft Model, 2D/3D Cell Cultures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- 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.
Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease.
The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: tumor biopsysingle tumor biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS
- Local recurrences are allowed
- Age ≥ 18 years
- Able and willing to undergo tumour biopsies or tumour sampling during surgery
- Localization of sarcoma enables safe biopsy or surgery
Key exclusion criteria (2 listed)
- Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
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 |
|---|---|---|
| tumor biopsybiopsy | Other | single arm |
Primary outcome
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas
Time frame: 4 months
take rate
The take-rate of fresh human PDX tumour material in nude mice.
Time frame: 4 months
take rate
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)
Time frame: 2 years after start of study
take rate
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.
Time frame: 6 weeks
take rate
A model for translational research
Time frame: 2 years after start of study
take rate
3 secondary outcomes
The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice
Time frame: 4 months after implantation of tumour material
Fractionation sensitivity on several STS subtypes in PDX.
Time frame: 4 months
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
Rick Haas, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tumor biopsy in people with Soft Tissue Sarcoma and Xenograft Model, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 7 Jun 2024. 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 Netherlands. 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 Rick Haas, MD, PhD (+31 20 512 9111, r.haas@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas (time frame: 4 months). The study lists 5 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 7 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.