Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Toxicity
Study Overview
Brief Summary
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.
Detailed Description
A total of 1000 patients with various diseases with the indication for hyperthermia in addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy) will be included in this registry protocol.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Toxicity
Time Frame: Through the study completion, up to 10 years
Toxicity assessment based on Common Toxicity Criteria Scoring
Effectivity
Time Frame: Through the study completion, up to 10 years
To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Pirus Ghadjar
Prof. Dr. med.
Charite University, Berlin, Germany