RadiotherapyCOMFORTATTOONCT05371795
Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device
A study testing Comfort Marker 2.0 and Lancets in people with Radiotherapy and Tattooing, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto at 1 site in Portugal.
Trial summary
Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Tattooing
- What is being tested?
- Comfort Marker 2.0 and Lancets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Oct 2021to Sep 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years old.
- Patients referred to our department to receive external beam radiation therapy.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Estimated fractionating schedule of at least 13 once-daily fractions.
- Written informed consent.
Who cannot join
- Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto Português de Oncologia do Porto Francisco Genti
Porto, 4200-072
About this study
Official title: Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)
Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®
Read the detailed description
A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)
- Conditions
- Radiotherapy, Tattooing
- Being tested
- Comfort Marker 2.0, Lancets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Marker 2.0Device
The set-up markings are created during the simulation session, after the CT simulation is acquired. For the experimental group, patients' markings are tattooed using an electric marking device developed for set-up marking, the Comfort Marker 2.0® (CM), designed by CIVCO medical solutions, using the 0.2mm deep application depth and the brand-included black pigment. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.
LancetsDevice
The set-up markings are created during the simulation session, after the CT simulation is acquired. For the control group, patients' markings are tattooed using a 28-gauge disposable lancet and india ink. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.
| Study group | Role | What they receive |
|---|---|---|
| Lancets | Active comparator | Not described Receives: Device: Lancets |
| Comfort Marker 2.0 | Experimental | Not described Receives: Device: Comfort Marker 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' comfort
Comfort is verbally assessed on the 11-point numeric pain scale. As more than one reference point is tattooed, the patients are asked to give an overall score to the procedure.
Measured: Day 1
Effectiveness
Effectiveness is assessed by the RTT team that delivered the daily fractions. Skin markings are individually evaluated at several periods, specifically at the first fraction, then every 5 fractions, and one last time in the last fraction of RT. These evaluations are scored on a 4-point graded scale (corresponding to bad, reasonable, good, and excellent).
Measured: up to 7 weeks
Secondary outcomes (2)
RTTs' satisfaction
The RTT that executed the tattooing is asked to score the ease of the process on a three-point scale (easy, medium, and hard).
Measured: Day 1
Cosmesis
A photographic assessment is performed. Every set-up marking is individually photographed on one of the last three days of treatment. All photographs are scored by independent observers (both physicians and RTTs) blind to patient identity and treatment allocation, on a five-point scale (corresponding from bad to excellent cosmesis).
Measured: one of the last three days of irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start18 Oct 2021
- Primary completion11 Mar 2022
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Miranda Pires, Instituto Portugues de Oncologia, Francisco Gentil, Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371795
- Sponsor's protocol ID
- CONFORTATTOO
- Acronym
- COMFORTATTOO
- Status last verified
- Jun 2022
- First submitted
- 26 Apr 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pires AM, Carvalho L, Santos AC, Vilaca AM, Coelho AR, Oliveira C, Costa C, Fernandes F, Moreira L, Lima J, Vieira R, Ferraz MJ, Silva M, Silva P, Matias R, Zorro S, Costa S, Sarandao S, Barros AF. Radiation Therapy Skin Marking with Lancets Versus Electric Marking Pen (COMFORTATTOO)-6 Months Results on Cosmesis, Fading, and Patients' Satisfaction From a Randomized, Double-Blind Trial. Adv Radiat Oncol. 2023 Nov 5;9(3):101404. doi: 10.1016/j.adro.2023.101404. eCollection 2024 Mar.
PubMed 38292889
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)
- ClinicalTrials.gov ID
- NCT05371795
- Acronym / sponsor ID
- COMFORTATTOO / CONFORTATTOO
- Conditions
- Radiotherapy, Tattooing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, PortoUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 12 May 2022 (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.
Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®
Detailed description
A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lancets | Active comparator | Device: Lancets |
| Comfort Marker 2.0 | Experimental | Device: Comfort Marker 2.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at least 18 years old.
- Patients referred to our department to receive external beam radiation therapy.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Estimated fractionating schedule of at least 13 once-daily fractions.
- Written informed consent.
Key exclusion criteria (1 listed)
- Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.
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 |
|---|---|---|
| Comfort Marker 2.0The set-up markings are created during the simulation session, after the CT simulation is acquired. For the experimental group, patients' markings are tattooed using an electric marking device developed for set-up marking, the Comfort Marker 2.0® (CM), designed by CIVCO medical solutions, using the 0.2mm deep application depth and the brand-included black pigment. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified. | Device | Comfort Marker 2.0 |
| LancetsThe set-up markings are created during the simulation session, after the CT simulation is acquired. For the control group, patients' markings are tattooed using a 28-gauge disposable lancet and india ink. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified. | Device | Lancets |
Primary outcome
Patients' comfort
Time frame: Day 1
Comfort is verbally assessed on the 11-point numeric pain scale. As more than one reference point is tattooed, the patients are asked to give an overall score to the procedure.
Effectiveness
Time frame: up to 7 weeks
Effectiveness is assessed by the RTT team that delivered the daily fractions. Skin markings are individually evaluated at several periods, specifically at the first fraction, then every 5 fractions, and one last time in the last fraction of RT. These evaluations are scored on a 4-point graded scale (corresponding to bad, reasonable, good, and excellent).
2 secondary outcomes
RTTs' satisfaction
Time frame: Day 1
Cosmesis
Time frame: one of the last three days of irradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 38292889Pires AM, Carvalho L, Santos AC, Vilaca AM, Coelho AR, Oliveira C, Costa C, Fernandes F, Moreira L, Lima J, Vieira R, Ferraz MJ, Silva M, Silva P, Matias R, Zorro S, Costa S, Sarandao S, Barros AF. Radiation Therapy Skin Marking with Lancets Versus Electric Marking Pen (COMFORTATTOO)-6 Months Results on Cosmesis, Fading, and Patients' Satisfaction From a Randomized, Double-Blind Trial. Adv Radiat Oncol. 2023 Nov 5;9(3):101404. doi: 10.1016/j.adro.2023.101404. eCollection 2024 Mar.
- Individual participant dataSharing planned: No
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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. 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?
A study testing Comfort Marker 2.0 and Lancets in people with Radiotherapy and Tattooing, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto at 1 site in Portugal.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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 Portugal. 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?
Results are not available in the source record.
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?
Patients' comfort (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371795, which also lists 1 linked publication.
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 10 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.