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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012892 |
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Date of registration:
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07/09/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Identification of miRNA relevant for diagnosis and prognosis of oral squamous cell carcinoma patients
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Scientific title:
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Identification of miRNA relevant for diagnosis and prognosis of oral squamous cell carcinoma patients - Id-Prog-Oral |
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Date of first enrolment:
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10/09/2017 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00012892 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Matthias
Zirk |
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Address:
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Kerpenerstr. 62
50937
Köln
Germany |
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Telephone:
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022147896564 |
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Email:
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matthias.zirk@uk-koeln.de |
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Affiliation:
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Uniklinik Köln-Abteilung für Mund-, Kiefer- und plastische Gesichtschirurgie- |
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Name:
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Matthias
Zirk |
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Address:
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Kerpenerstr. 62
50937
Köln
Germany |
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Telephone:
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022147896564 |
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Email:
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matthias.zirk@uk-koeln.de |
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Affiliation:
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Uniklinik Köln-Abteilung für Mund-, Kiefer- und plastische Gesichtschirurgie- |
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Key inclusion & exclusion criteria
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Inclusion criteria: -Written informed consent
- Indication for surgical treatment of head and neck malignoma in accordance with local tumorboard vote.
Exclusion criteria: - Pregnancy
- Patients < 18 years
- Patients who are unable to give informed consent due to their dependence on alcohol, drugs or mind-altering medication
- Patients who are unable to give informed consent due to their psychiatric disorder
- Patients who are unable to give informed consent due to any kind of medical, psychological or other personal disorder
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of floor of mouth
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Malignant neoplasm of other and unspecified parts of mouth
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C01
C02
C03
C04
C05
C06
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Malignant neoplasm of base of tongue
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Malignant neoplasm of gum
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Malignant neoplasm of other and unspecified parts of tongue
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Malignant neoplasm of palate
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Intervention(s)
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Group 1: MicroRNA expression profiles of patients' various pTMN stage are compared to each other. Samples are harvested pre- and post-surgery.
Healthy patients who receive oral surgery for reasons other than any kind of malignancy (mostly orthognathic surgery) serve as control group.
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Primary Outcome(s)
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MicroRNA are obtained from patients' tissue and blood samples. Analysis of micrcoRNA expression profiles from diverse pTNM stages. Can certain expression profiles indicate early metastatic spread or rapid tumor progression? Expression profiles of all enrolled patients are analyzed after 2 years of clinical trial, preliminary results are assessed biannually.
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Secondary Outcome(s)
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Analysis of micrcoRNA expression profiles from pT1,2 OSCC (oral squamous cell carcinoma) with/without metastatic spread. Are indicators for early metastatic spread detectable?
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Source(s) of Monetary Support
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Köln Fortune ProjektForschungsdekanat
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Ethics review
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Status: Approved
Approval date: 29/04/2016
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
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