Prospective Hyperthermia Database in Cancer Patients (HT Register) (HTRegister)

August 14, 2023 updated by: Pirus Ghadjar

Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Clinic for Radio - Oncology and Radiotherapy
        • Contact:
      • Berlin, Germany, 13353
        • Recruiting
        • Clinic for Radio - Oncology and Radiotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperthermie Register
Hyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through the study completion, up to 10 years
Toxicity
Time Frame: Through the study completion, up to 10 years
Toxicity assessment based on Common Toxicity Criteria Scoring
Through the study completion, up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirus Ghadjar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTRegister2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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