Prospective Hyperthermia Database in Cancer Patients (HT Register)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPirus Ghadjar
About this trial
This monocentric study registry records all cancer patients at the Charité which are treated with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the general application and to obtain an accurate risk-benefit balance
After confinement in this database are the patients prospectively in order to complications, disease status and survival status tracked.
Furthermore there is the possibility in the course of this study to an optional take part in translational accompanying research with the aim of prognostic factors for response to hyperthermia treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Contrazeption with female patients at the capable of bearing children age
Written agreement is present (DvH, ICH-GCP)
Patients, who participate at the same time in a interventional study, can nevertheless in this register study participate if this none Exclusion criterion for the interventional study represents.
With children must the treatment with one of the GPOH agreed Pattern take place
Disqualifiers
Exclusion criteria for the hyperthermia (such as hip prosthesis in the therapeutic area, metal implants/marker, patients with cardiac pacemakers)
mental disease, what the proper study participation does not allow.
Trial population
It is planned to include the first 1.000 patients in this prospective database. Because of the characters in the database is a certain gender distribution not laid down . Confinement are capable of all patients in the Charité , which has a hyperthermia treatment , regardless of age or gender
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Hyperthermie Register
Other intervention* die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C), * die Dauer der Anwendung und * die simultane Therapie mit Chemo- und/oder Strahlentherapie
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Hyperthermie Register1 intervention
Trial outcomes
Primary outcomes
1
Effectivity
To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival
Time frame
Through the study completion, up to 10 years2
Toxicity
Toxicity assessment based on Common Toxicity Criteria Scoring
Time frame
Through the study completion, up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pirus Ghadjar
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Source ClinicalTrials.gov