Proton Therapy Medical Registry

Cancer, Therapy-Related Clinical Trial

Official title:

Proton Therapy Medical Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151952
• Other study ID #: Proton
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2050

Study information

• Verified date: November 2021
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Felipe A Calvo
• Phone: +34913532920
• Email: fcalvom[@]unav.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Clínica Universidad de Navarra Proton Therapy Unit is establishing a registry to capture the full radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The objectives are parameters prescribed and to have all patients treated at the proton therapy unit to be included in the registry to enable future analysis of treatment outcomes to assist in understanding, which patients can benefit from the use of protons.

Description:

Proton based radiation therapy has considerable dosimetric advantages over the standard photon based external beam radiation therapy, with an increased cost. Now, the clinical advantages, however, may not be identified in general, even with the improved dose distributions. In a large-scale evaluation, in time of personalized/ precision medicine, the impact of dosimetric benefit int clinical benefit meds registration studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: April 1, 2050
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients treated at the proton center

Exclusion Criteria:

• Any other than what is supplied in the inclusion criteria

Related Conditions & MeSH terms

• Cancer, Therapy-Related
• Neoplasms, Second Primary

Intervention

Radiation:
• Other: Registry
Registry of cancer patients who receive proton radiation therapy.

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Mesure	Clinical outcomes will be obtains from electronic chart including: images, blood test, pathology and clinical reports	20 years