Trial document
This trial has been registered retrospectively.
DRKS00010924
Trial Description
Title
Biomarker associated with the radiation therapy of renal cell cancer.
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
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Brief Summary in Scientific Language
This explorative study examines whether the response of renal cell cancer to stereotactic radiotherapy (SBRT) in 10 patients with von Hippel-Lindau syndrome correlates with modifications in gene expression in peripheral blood and urine. These data can be used to draw conclusions regarding the underlying mechanisms of SBRT (e.g. apoptosis, inflammation, immune response) to optimize dose, application mode and synergistic adjuvant therapies.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00010924
- 2016/09/23
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- yes
- Approved
- 266/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
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Health Condition or Problem studied
- C64 - Malignant neoplasm of kidney, except renal pelvis
Interventions/Observational Groups
- During the course of radiation therapy, expression profiles and proteomic analyses from blood and urine will be used to elucidate the processes induced by radiation.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Treatment
- Single (group)
- I
- N/A
Primary Outcome
Modifications of biomarker (urine, blood) in 10 patients
Secondary Outcome
n/a
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2016/01/15
- 10
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
VHL patients with RCC and SBRT
Exclusion Criteria
Patients with Hb < 10 g/dL, and patients unable to collect substantial quantities of urine (≥ 250 ml)
Addresses
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start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Ms. Prof. Dr. med. Anca Ligia Grosu
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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- anca.grosu at uniklinik-freiburg.de
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
- Ms. PD Dr. Emily Kim
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 761 270 94620
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- emily.kim at uniklinik-freiburg.de
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- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Mr. Dr. med. Simon Kirste
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 761 270 94510
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- simon.kirste at uniklinik-freiburg.de
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Sources of Monetary or Material Support
-
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- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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