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A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02910895
Acronym
SarcomaPDX
Enrollment
40
Registered
2016-09-22
Start date
2017-09-09
Completion date
2024-09-30
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2D/3D Cell Cultures, Soft Tissue Sarcoma, Xenograft Model

Brief 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. 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.

Interventions

OTHERtumor biopsy

biopsy

Sponsors

KU Leuven
CollaboratorOTHER
The Netherlands Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
A model for translational research2 years after start of studytake rate
The take-rate of fresh human PDX tumour material in nude mice.4 monthstake rate
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)2 years after start of studytake rate
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.6 weekstake rate
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas4 monthstake rate

Secondary

MeasureTime frameDescription
Fractionation sensitivity on several STS subtypes in PDX.4 monthstake rate
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing1 monthtake rate of continuous growth
The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice4 months after implantation of tumour materialtake rate of continuous growth of implantation of tumor material

Countries

Netherlands

Contacts

Primary ContactRick Haas, MD, PhD
r.haas@nki.nl+31 20 512 9111
Backup ContactAstrid Scholten, MD, PhD
a.scholten@nki.nl+31 20 512 9111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026