NCT05151952

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
291mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Apr 2020Apr 2050

Study Start

First participant enrolled

April 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2050

Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

10 years

First QC Date

November 11, 2021

Last Update Submit

November 25, 2021

Conditions

Cancer, Therapy-Related

Keywords

Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer

Outcome Measures

Primary Outcomes (1)

  • Outcome Mesure

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

    20 years

Study Arms (1)

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

Interventions

Other: RegistryRADIATION

Registry of cancer patients who receive proton radiation therapy.

Cancer patients receiving proton radiation therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients with proton therapy

You may qualify if:

  • All patients treated at the proton center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, 28027, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms, Second PrimaryNeoplasms

Central Study Contacts

Felipe A Calvo

CONTACT

+34913532920fcalvom@unav.es

UCEC UCEC

CONTACT

eecc@unav.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 9, 2021

Study Start

April 1, 2020

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2050

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

ES(2)