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Sarcoma Patient Derived Xenografts (SarcomaPDX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02910895
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : February 21, 2018
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Xenograft Model 2D/3D Cell Cultures Other: tumor biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
single arm
single tumor biopsy
Other: tumor biopsy

Primary Outcome Measures :
  1. A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas [ Time Frame: 4 months ]
    take rate

  2. The take-rate of fresh human PDX tumour material in nude mice. [ Time Frame: 4 months ]
    take rate

  3. A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments) [ Time Frame: 2 years after start of study ]
    take rate

  4. A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas. [ Time Frame: 6 weeks ]
    take rate

  5. A model for translational research [ Time Frame: 2 years after start of study ]
    take rate

Secondary Outcome Measures :
  1. 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 ]
    take rate of continuous growth of implantation of tumor material

  2. Fractionation sensitivity on several STS subtypes in PDX. [ Time Frame: 4 months ]
    take rate

  3. To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing [ Time Frame: 1 month ]
    take rate of continuous growth

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02910895

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Contact: Rick Haas, MD, PhD +31 20 512 9111
Contact: Astrid Scholten, MD, PhD +31 20 512 9111

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Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Rick Haas, MD, PhD    +31 20 512 9111   
Contact: Astrid Scholten, MD, PhD    +31 20 512 9111   
Sponsors and Collaborators
The Netherlands Cancer Institute
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Principal Investigator: Rick Haas, MD, PhD The Netherlands Cancer Institute

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Responsible Party: The Netherlands Cancer Institute Identifier: NCT02910895     History of Changes
Other Study ID Numbers: N16STS
NL58626.031.16 ( Registry Identifier: CCMO )
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type