106 Ruthenium Plaque BrachytherapyNCT04577742
Uveal Melanoma and Brachytheraphy: Long-term Outcomes.
An observational study of 106 Ruthenium Plaque Brachytherapy and Uveal Melanoma, run by Federico II University at 1 site in Italy.
Trial summary
This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- 106 Ruthenium Plaque Brachytherapy, Uveal Melanoma
- What is being tested?
- 106 Ruthenium plaque brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2011to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: The participans were older than 40 years with uveal melanoma and they underwent Ruthenium 106 brachytherapy
Who may be able to join
- age older than 40 years
- diagnosis of uveal melanoma
Who cannot join
- age older than 80 years
- No diagnosis of uveal melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes in Uveal Melanoma After Ruthenium-106 Brachytherapy
This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020
- Conditions
- 106 Ruthenium Plaque Brachytherapy, Uveal Melanoma
- Being tested
- 106 Ruthenium plaque brachytherapy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
106 Ruthenium plaque brachytherapyRadiation
All patients, affected by uveal melanoma, were treated with 106 Ruthenium plaque brachytherapy to a total dose of 100 Gy to the tumor apex. The time of implant duration was calculated according to the conventional central-axis-point dose calculation
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate long-term outcomes in patients underwent brachytherapy for uveal melanoma
To investigate the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival
Measured: Mean follow-up was 4 years (3 months-9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Feb 2011
- Primary completion20 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 106 Ruthenium Plaque BrachytherapyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577742
- Sponsor's protocol ID
- 2020/106
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes in Uveal Melanoma After Ruthenium-106 Brachytherapy
- ClinicalTrials.gov ID
- NCT04577742
- Acronym / sponsor ID
- 2020/106
- Conditions
- 106 Ruthenium Plaque Brachytherapy, Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 Oct 2020 (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.
This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 40 years with uveal melanoma and they underwent Ruthenium 106 brachytherapy
Key inclusion criteria (2 listed)
- age older than 40 years
- diagnosis of uveal melanoma
Key exclusion criteria (2 listed)
- age older than 80 years
- No diagnosis of uveal melanoma
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 |
|---|---|---|
| 106 Ruthenium plaque brachytherapyAll patients, affected by uveal melanoma, were treated with 106 Ruthenium plaque brachytherapy to a total dose of 100 Gy to the tumor apex. The time of implant duration was calculated according to the conventional central-axis-point dose calculation | Radiation | – |
Primary outcome
To evaluate long-term outcomes in patients underwent brachytherapy for uveal melanoma
Time frame: Mean follow-up was 4 years (3 months-9 years)
To investigate the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 106 Ruthenium Plaque Brachytherapy and Uveal Melanoma, run by Federico II University at 1 site in Italy.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate long-term outcomes in patients underwent brachytherapy for uveal melanoma (time frame: Mean follow-up was 4 years (3 months-9 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 8 Oct 2020.