Proton Therapy Medical Registry

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05151952
• Collaborator: (none)
• Enrollment: 6,000
• Locations: 2
• Anticipated Duration (Months): 360
• Patients Per Site: 3000
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Therapy-Related	Radiation: Other: Registry

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 6000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Proton Therapy Medical Registry
• Actual Study Start Date: Apr 1, 2020
• Anticipated Primary Completion Date: Apr 1, 2030
• Anticipated Study Completion Date: Apr 1, 2050

Arms and Interventions

Arm	Intervention/Treatment
Cancer patients receiving proton radiation therapy Cancer patients receiving proton radiation therapy, Registry of cancer patients who receive proton radiation therapy to crack disease and toxicity outcomes.	Radiation: Other: Registry; Registry of cancer patients who receive proton radiation therapy.

Outcome Measures

Primary Outcome Measures

1. Outcome Mesure [20 years]

   Clinical outcomes will be obtains from electronic chart including: images, blood test, pathology and clinical reports

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients treated at the proton center

Exclusion Criteria:

• Any other than what is supplied in the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Universidad de Navarra	Pamplona	Navarra	Spain	31008
2	Clinica Universidad de Navarra	Madrid		Spain	28027

Sponsors and Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
• ClinicalTrials.gov Identifier: NCT05151952
• Other Study ID Numbers: Proton
• First Posted: Dec 9, 2021
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra: Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer
• Additional relevant MeSH terms: Neoplasms, Second Primary

Study Results

No Results Posted as of Dec 9, 2021