Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio) (HNprädBio)
|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.|
|ClinicalTrials.gov Identifier: NCT02059668|
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : November 15, 2021
The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.
Potential biomarkers from a previous retrospective study will be validated in this prospective study.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Biological: Biomarker analyses head & neck cancer tissue, blood specimen|
Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.
Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.
Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.
The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.
|Study Type :||Observational|
|Estimated Enrollment :||550 participants|
|Official Title:||Observational Study on Biomarkers in Head and Neck Cancer|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||September 2023|
Biomarker analyses head & neck cancer tissue, blood specimen
Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer.
Biological: Biomarker analyses head & neck cancer tissue, blood specimen
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
- local recurrence free survival [ Time Frame: after 2 years ]
- disease-free survival [ Time Frame: after 2 years ]
- metastases-free survival [ Time Frame: after 2 years ]
- overall survival [ Time Frame: after 2 years ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT02059668
|Contact: Mechthild Krause, Prof.||+49 351 458 email@example.com|
|Prof. Anca-Ligia Grosu||Recruiting|
|Freiburg, Baden-Wuerttemberg, Germany, 79106|
|Contact: Anca-Ligia Grosu, Prof. +49 761 270 94610 firstname.lastname@example.org|
|Principal Investigator: Ana-Ligia Grosu, Prof.|
|Prof. Jürgen Debus||Recruiting|
|Heidelberg, Baden-Wuerttemberg, Germany, 69120|
|Contact: Jürgen Debus, Prof. +49 6221 / 56 82 01 Juergen.Debus@med.uni-heidelberg.de|
|Principal Investigator: Jürgen Debus, Prof.|
|Prof. Daniel Zips||Recruiting|
|Tübingen, Baden-Wuerttemberg, Germany, 72016|
|Contact: Daniel Zips, Prof. +49 7071/29-8 21 65 ROInfo@med.uni-tuebingen.de|
|Principal Investigator: Daniel Zips, Prof.|
|Prof. Claus Belka||Recruiting|
|München, Bavaria, Germany, 81377|
|Contact: Claus Belka, Prof. +49 89 7095 4520 Claus.Belka@med.uni-muenchen.de|
|Principal Investigator: Claus Belka, Prof.|
|Prof. Stephanie Combs||Recruiting|
|München, Bavaria, Germany, 81675|
|Contact: Stephanie Combs, Prof. +49 89 41 40-45 02 email@example.com|
|Principal Investigator: Stephanie Combs, Prof.|
|Prof. Claus Rödel||Recruiting|
|Frankfurt, Hesse, Germany, 60590|
|Contact: Claus Rödel, Prof. + 49 69 / 6301-5130 firstname.lastname@example.org|
|Principal Investigator: Claus Rödel, Prof.|
|Prof. Martin Stuschke||Recruiting|
|Essen, North Rhine-Westphalia, Germany, 45147|
|Contact: Martin Stuschke, Prof. +49 201 / 723-23 20 email@example.com|
|Principal Investigator: Martin Stuschke, Prof.|
|Prof. Mechthild Krause||Recruiting|
|Dresden, Saxony, Germany, 01307|
|Contact: Mechthild Krause, Prof. +49 351 458 2238 firstname.lastname@example.org|
|Principal Investigator: Mechthild Krause, Prof.|
|Prof. Volker Budach||Recruiting|
|Berlin, Germany, 10117|
|Contact: Volker Budach, Prof. +49 30 450 527 152|
|Principal Investigator: Volker Budach, Prof.|
|Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt||Recruiting|
|Dresden, Germany, 01067|
|Contact: Schreiber Andreas, Dr. email@example.com|
|Principal Investigator:||Mechthild Krause, Prof.||Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology|