Cancer, Therapy-RelatedNCT05151952
Proton Therapy Medical Registry
An observational study of Cancer, Therapy-Related, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Therapy-Related
- What is being tested?
- Other: Registry
- Type of treatment
- Surgery or procedure
- How many people
- 6,000 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2020to 1 Apr 2050
- How long will I take part?
- 20 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: Cancer patients with proton therapy
Who may be able to join
- All patients treated at the proton center
Who cannot join
- Any other than what is supplied in the inclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
UCEC UCEC contact
Spain2 sites, 2 recruiting
- Recruiting
Clinica Universidad de Navarra
Madrid, 28027
Felipe A Calvo, +34913531920 ext. 7478, fcalvom@uanv.es
Jose Javier Aristu
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Felipe A Calvo, +34948255400, fcalvom@unav.es
About this study
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.
Read the 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.
- Conditions
- Cancer, Therapy-Related
- Being tested
- Other: Registry
- Keywords
- Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer
- Medical subject headings
- Neoplasms, Second Primary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: RegistryRadiation
Registry of cancer patients who receive proton radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Mesure
Clinical outcomes will be obtains from electronic chart including: images, blood test, pathology and clinical reports
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Apr 2020
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Therapy-RelatedStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151952
- Sponsor's protocol ID
- Proton
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy Medical Registry
- ClinicalTrials.gov ID
- NCT05151952
- Acronym / sponsor ID
- Proton
- Conditions
- Cancer, Therapy-Related
- Keywords
- Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2050 (estimated)
- First posted
- 9 Dec 2021 (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.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients receiving proton radiation therapy | – | Radiation: Other: RegistryCancer patients receiving proton radiation therapy, Registry of cancer patients who receive proton radiation therapy to crack disease and toxicity outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients with proton therapy
Key inclusion criteria (1 listed)
- All patients treated at the proton center
Key exclusion criteria (1 listed)
- Any other than what is supplied in the inclusion criteria
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 |
|---|---|---|
| Other: RegistryRegistry of cancer patients who receive proton radiation therapy. | Radiation | Cancer patients receiving proton radiation therapy |
Primary outcome
Outcome Mesure
Time frame: 20 years
Clinical outcomes will be obtains from electronic chart including: images, blood test, pathology and clinical reports
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 9 Dec 2021.
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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.
UCEC UCEC contact
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 Cancer, Therapy-Related, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
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 1 inclusion and 1 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 9 Dec 2021. 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 Spain. 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 Felipe A Calvo (+34913532920 ext. 7478, fcalvom@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Mesure (time frame: 20 years). 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 9 Dec 2021.