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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma; Xenograft Model; 2D/3D Cell Cultures
• Intervention / Treatment: Other: tumor biopsy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rick Haas, MD, PhD; Phone Number: +31 20 512 9111; Email: r.haas@nki.nl
• Study Contact Backup: Name: Astrid Scholten, MD, PhD; Phone Number: +31 20 512 9111; Email: a.scholten@nki.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • Netherlands Cancer Institute
    • Contact: Rick Haas, MD, PhD; Phone Number: +31 20 512 9111; Email: r.haas@nki.nl
    • Contact: Astrid Scholten, MD, PhD; Phone Number: +31 20 512 9111; Email: a.scholten@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm; single tumor biopsy	Other: tumor biopsy; biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas	take rate	4 months
The take-rate of fresh human PDX tumour material in nude mice.	take rate	4 months
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)	take rate	2 years after start of study
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.	take rate	6 weeks
A model for translational research	take rate	2 years after start of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fractionation sensitivity on several STS subtypes in PDX.	take rate	4 months
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing	take rate of continuous growth	1 month

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Rick Haas, MD, PhD, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2017
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimated): September 22, 2016

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: N16STS; NL58626.031.16 (Registry Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No