Prospective Hyperthermia Database in Cancer Patients (HT Register)

Cancer Clinical Trial

— HTRegister  

Official title:

Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993910
• Other study ID #: HTRegister2014
• Status: Recruiting
• Start date: November 1, 2014
• Est. completion date: October 31, 2028

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: Pirus Ghadjar, PD Dr.
• Phone: +4930450657055
• Email: pirus.ghadjar[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Fever
• Hyperthermia

Intervention

Other:
• Hyperthermie Register
die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C), die Dauer der Anwendung und die simultane Therapie mit Chemo- und/oder Strahlentherapie

Locations

Country	Name	City	State
Germany	Clinic for Radio - Oncology and Radiotherapy	Berlin
Germany	Clinic for Radio - Oncology and Radiotherapy	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Pirus Ghadjar

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectivity	To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival	Through the study completion, up to 10 years
Primary	Toxicity	Toxicity assessment based on Common Toxicity Criteria Scoring	Through the study completion, up to 10 years