Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: DRKS00010924

Trial Description

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Title

Biomarker associated with the radiation therapy of renal cell cancer.

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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.

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Organizational Data

DRKS-ID: DRKS00010924
Date of Registration in DRKS: 2016/09/23
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 266/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

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Health Condition or Problem studied

ICD10: C64 - Malignant neoplasm of kidney, except renal pelvis

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Interventions/Observational Groups

Arm 1: 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.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Treatment
Assignment: Single (group)
Phase: I
Off-label Drug use: N/A

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Primary Outcome

Modifications of biomarker (urine, blood) in 10 patients

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Secondary Outcome

n/a

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Klinik für Strahlenheilkunde, Freiburg im Breisgau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2016/01/15
Target Sample Size: 10
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

VHL patients with RCC and SBRT

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Exclusion Criteria

Patients with Hb < 10 g/dL, and patients unable to collect substantial quantities of urine (≥ 250 ml)

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Addresses

Primary Sponsor
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- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Ms. Prof. Dr. med. Anca Ligia Grosu
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: anca.grosu at uniklinik-freiburg.de
- URL: [---]*
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Contact for Scientific Queries
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- Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
- Ms. PD Dr. Emily Kim
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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- Telephone: +49 761 270 94620
- Fax: [---]*
- E-mail: emily.kim at uniklinik-freiburg.de
- URL: [---]*
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Contact for Public Queries
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- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Mr. Dr. med. Simon Kirste
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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- Telephone: +49 761 270 94510
- Fax: [---]*
- E-mail: simon.kirste at uniklinik-freiburg.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
- Robert-Koch-Str. 3
- 79106 Freiburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.