Proton Therapy Medical Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer, Therapy-Related
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Felipe A Calvo; Phone Number: 7478 +34913532920; Email: fcalvom@unav.es
• Study Contact Backup: Name: UCEC UCEC; Email: eecc@unav.es

Study Locations

• Spain
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra
    • Contact: Felipe A Calvo; Phone Number: 7478 +34913531920; Email: fcalvom@uanv.es
    • Principal Investigator: Jose Javier Aristu
    • Principal Investigator: Felipe A Calvo
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra
      • Contact: Felipe A Calvo; Phone Number: +34948255400; Email: fcalvom@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with proton therapy

Description

Inclusion Criteria:

• All patients treated at the proton center

Exclusion Criteria:

• Any other than what is supplied in the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): April 1, 2030
• Study Completion (Anticipated): April 1, 2050

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: Proton

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No