English
Deutsch
Study center
Our study center conducts several clinical studies in oncology, allergology/angioedema and otology at all times of the year. We need your help as a patient to successfully manage to complete those studies.
What is a clinical study and how is it conducted?
New pharmaceuticals, diagnostic procedures and medical devices need to undergo clinical studies before they can be marketed. These studies aim to evaluate their safety and effectiveness. They are conducted with volunteers (probands.
A specific study protocol lays out among other things the substance to be tested, the duration of the study, the planned study visits and examinations, the aims of the study and how to deal with adverse events.
The study protocols are approved by the ethic committee of the medical faculty of the TUM and other independent committees (e.g. Paul-Ehrlich-Institut, Bundesamt für Arzneimittel und Medizinprodukte, Bundesamt für Strahlenschutz).
All volunteers can opt out of the study at any time without further obligations.
Which types of study do exist?
Our study center primarily conducts controlled studies. In this type of study only a part of the probands receive the study medication. All other probands either receive the current standard therapy or a placebo. Probands are usually randomly assigned to one of the two groups (randomization).
Most of the studies are conducted in a double-blind fashion. In this setting neither proband nor investigator know to which study group the proband has been assigned.
Open study settings in which all probands and investigators know which substance they are receiving are much rarer.
Which types of drug trials do exist?
All drugs have to undergo certain study phases before they can be approved for market access.
Phase I
In this phase a study drug which has formerly only been tested in cell cultures and animals is tested in healthy volunteers for the first time.
Phase I studies aim to determine whether the study drug is safe, if the effects are comparable to the effects observed in animals, how the study drugs is distributed and metabolized in humans.
Phase II
In this phase drugs are used in sick volunteers for the first time. These studies serve to determine the effectivity, tolerability and the optimal dose of a drug.
Phase III
In this phase the results of the phase-II-study are being corroborated in a large patient cohort.
This usually takes place in a double blinded randomized fashion in which the new drug is compared with standard medication or placebo. Market access can be applied for after completion of these studies.
Phase IV
These studies are performed after market approval of a drug. Patients are monitored while they use a newly approved drug in routine therapy. These trials aim to monitor rare adverse events and to verify the effectivity of the medication under real life conditions.
Further studies are in preparation, if you are interested to participate in one of our studies please contact us by mail at: studienzentrum-hno@mri.tum.de
- Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
- KOHACIN Study
Prospective study of therapy monitoring in head and neck cancer by detection of circulating tumor nucleic acids and proteins in saliva and peripheral blood.
- CUP
Local immune response in CUP syndrome compared with oropharyngeal carcinoma.
- HN präd Bio
Therapeutic success of radiotherapy based on biomarkers, no more patient inclusion.
- Xerostomy Oral Spray Study
We are regularly involved in pioneering new therapeutic worldwide studies. If you would like to get more information about our studies, please send an e-mail to allergie@mri.tum.de(link sends e-mail).
With our studies we enable interested patients* to participate in new therapie options at an early stage. This concerns mainly pollen and mite allergies with and without asthma and chronic sinusitis with nasal polyps in adults. For example, we have contributed to studies for allergen immunotherapy for grass allergy sufferers with peptides and to new concepts for grass and birch pollen allergies (new injection therapies). We are also involved in pioneering studies for new therapies with antibodies in chronic sinusitis with nasal polyps.
Furthermore, we are conducting in-house research projects with the Center for Allergy and Environment (ZAUM(link is external)) (e.g. the PACIFIC study and the ADAPT study (ADAPT-Studie(link is external)). Here we investigate long-term biomarkers for allergen immunotherapy.
Further information on allergy studies throughout Germany can also be found at the study portal of the Allergy Information Service(link is external).
Ongoing studies
- ADAPT study
Within the framework of our study we would like to test diagnostic procedures in order to cooperate in the development of new diagnostic methods. No more patients can be enrolled. More information here(link is external) and at the Allergy Information Service(link is external).
- PACIFIC study
Long-term study for biomarkers for allergy vaccination.
Upcoming studies
We are started two new studies in 2020 for the treatment of chronic rhinosinusitis with nasal polyps.
Completed studies
SYNAPSE (study on the treatment of chronic rhinosinusitis with nasal polyps with mepolizumab), TT04 (study on specific immunotherapy with a birch pollen tablet), PQ-Birch (studies on specific immunotherapy with a birch pollen injection).
- Parotid Redon study
Morbidity of parotidectomy for benign parotid tumors with and without redon drainage
Start in October 2020, patient enrollment by October 2021.
- MASAI study
Sjögen syndrome sonographic study of disease duration, start in October 2020, patient inclusion by December 2020.
- SHP643-402
A three-year, non-interventional, prospective, multicenter study to evaluate the long-termeffectiveness of lanadelumab in real-world clinical practice, patient inclusion possible.
- Elisa
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults, Duration through 10/30/2025, Patient Enrollment Sleep Laboratory Studies through December 2024.
- ADHERE-UAS Registry
Outcome of Upper Airway Stimulation Therapy for Obstructive Sleep Apnea Registry, duration through 12/31/2023, patient inclusion possible through December 2024.
- Snoring sounds in OAS patients
Acoustic analysis of snoring sounds in the context of upper airway stimulation in OAS patients, duration until December 31, 2021, patient inclusion possible until November 2021.
- DREAM study
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea, FDA approval study for bilateral hypoglossal nerve stimulation, study start end of 2020 - patient inclusion possible until March 2021.
In phoniatrics/logopedics, various studies are conducted on swallowing and voice.
In the area of dysphagia, these include: Early detection of dysphagia in ALS, reduction of aspiration risk through the use of a medical drinking cup each in cooperation with the Neurological Clinic and Polyclinic at the Klinikum rechts der Isar. The study: "Is the Munich Swallowing Score (MUCSS) a valid instrument for course documentation and outcome measurement in the therapy of neurogenic dysphagia" with Dr. phil. Gudrun Bartolome, Dr. med. Heidrun Schröter-Morasch, Clinic for Early Rehabilitation and Physical Medicine, Klinikum Bogenhausen. Further research is dedicated to swallowing and voice function after head and neck tumor therapy.
Our voice research interests are in: Laryngeal and pharyngeal movements during inner singing. Voice training without voice – vocal tract adaptation using proprioceptive biofeedback in singers. Voice training without voice – proprioceptive and visual biofeedback in deaf people together with Dr. Hoyer from Fraunhofer Institute Munich.
- Early detection of dysphagia in ALS, patient inclusion from September 2020.
- Bavarian State Opera: Prevalence of SARS-CoV-2 in artistic staff in the State Opera: the OPSAS, patient inclusion from September 2020 to April 2021.
- Is the MUCSS (Munich Swallowing Score) a valid instrument for follow-up documentation and outcome measurement in the therapy of neurogenic dysphagia, no more patient inclusion possible.
- Swallowing and voice function after head and neck tumor therapy, no patient inclusion possible anymore.
- Voice training without voice - proprioceptive and visual biofeedback for the deaf, no patient inclusion possible anymore.
If you are interested in participating in the study, or have any questions, please feel free to contact us at any time. Our contact information can be found below:
Phone +49 89 4140 6969
E-Mail(link sends e-mail)
