HyperthermiaHTRegisterNCT05993910
Prospective Hyperthermia Database in Cancer Patients (HT Register)
An observational study of Hyperthermia and Cancer, run by Pirus Ghadjar at 2 sites in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperthermia, Cancer
- What is being tested?
- Hyperthermie Register
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Nov 2014to 31 Oct 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Clinic for Radio - Oncology and Radiotherapy
Berlin, 13353
Pirus Ghadjar, Prof Dr., +4930450657055, pirus.ghadjar@charite.de
- Recruiting
Clinic for Radio - Oncology and Radiotherapy
Berlin, 13353
Pirus Ghadjar, Prof. Dr., +4930450657055, pirus.ghadjar@charite.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperthermia, Cancer
- Being tested
- Hyperthermie Register
- Keywords
- Hyperthermia E02.565, HTRegister
- Medical subject headings
- Hyperthermia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermie RegisterOther
- die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C),
- die Dauer der Anwendung und
- die simultane Therapie mit Chemo- und/oder Strahlentherapie
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermie Register | Hyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone Receives: Other: Hyperthermie Register |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectivity
To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival
Measured: Through the study completion, up to 10 years
Toxicity
Toxicity assessment based on Common Toxicity Criteria Scoring
Measured: Through the study completion, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Nov 2014
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Pirus Ghadjar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pirus Ghadjar, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993910
- Sponsor's protocol ID
- HTRegister2014
- Acronym
- HTRegister
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)
- ClinicalTrials.gov ID
- NCT05993910
- Acronym / sponsor ID
- HTRegister / HTRegister2014
- Conditions
- Hyperthermia, Cancer
- Keywords
- Hyperthermia E02.565, HTRegister
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pirus GhadjarUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermie Register | – | Other: Hyperthermie RegisterHyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Hyperthermie Register |
Primary outcome
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
Toxicity
Time frame: Through the study completion, up to 10 years
Toxicity assessment based on Common Toxicity Criteria Scoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthermia and Cancer, run by Pirus Ghadjar at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pirus Ghadjar, PD Dr. (+4930450657055, pirus.ghadjar@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectivity (time frame: Through the study completion, up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.