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

Soft Tissue Sarcoma Clinical Trial

— SarcomaPDX  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02910895
• Other study ID #: N16STS
• Secondary ID: NL58626.031.16
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2017
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: The Netherlands Cancer Institute
• Contact: Rick Haas, MD, PhD
• Phone: +31 20 512 9111
• Email: r.haas[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• tumor biopsy
biopsy

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	KU Leuven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas	take rate	4 months
Primary	The take-rate of fresh human PDX tumour material in nude mice.	take rate	4 months
Primary	A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)	take rate	2 years after start of study
Primary	A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.	take rate	6 weeks
Primary	A model for translational research	take rate	2 years after start of study
Secondary	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	4 months after implantation of tumour material
Secondary	Fractionation sensitivity on several STS subtypes in PDX.	take rate	4 months
Secondary	To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing	take rate of continuous growth	1 month