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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
tumor biopsy
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Netherlands Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm

Arm Description

single tumor biopsy

Outcomes

Primary Outcome Measures

A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas
take rate
The take-rate of fresh human PDX tumour material in nude mice.
take rate
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)
take rate
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.
take rate
A model for translational research
take rate

Secondary Outcome Measures

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
Fractionation sensitivity on several STS subtypes in PDX.
take rate
To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing
take rate of continuous growth

Full Information

First Posted
July 21, 2016
Last Updated
July 21, 2023
Sponsor
The Netherlands Cancer Institute
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02910895
Brief Title
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Xenograft Model, 2D/3D Cell Cultures

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Haas, MD, PhD
Phone
+31 20 512 9111
Email
r.haas@nki.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid Scholten, MD, PhD
Phone
+31 20 512 9111
Email
a.scholten@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Haas, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick Haas, MD, PhD
Phone
+31 20 512 9111
Email
r.haas@nki.nl
First Name & Middle Initial & Last Name & Degree
Astrid Scholten, MD, PhD
Phone
+31 20 512 9111
Email
a.scholten@nki.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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