Skin CarcinomaPRURITCCNCT03290989
Itch and Pain Characteristics in Skin Carcinomas
An observational study of Skin Carcinoma and Skin Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Carcinoma, Skin Cancer, Pruritus
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 31 Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From 1 April 2015 to 31 July 2015, all patients presenting with a skin lesion suspicious for carcinoma (BCC or SCC) at the Department of Dermatology of the Military Hospital in Brest were included in the study.
Who may be able to join
- all patients with suspected skin carcinoma aged 18 years or more
Who cannot join
- age under 18 years,
- inability to complete the questionnaire because of cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.
- Conditions
- Skin Carcinoma, Skin Cancer, Pruritus
- Medical subject headings
- Skin Neoplasms, Pruritus
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate characteristics of pruritus in skin carcinomas
Questions about characteristics
Measured: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)
Evaluate characteristics of pruritus in skin carcinomas
Numerical visual scale (EVA)
Measured: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Evaluate characteristics of pruritus in skin carcinomas
5D-itch scale
Measured: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Evaluate characteristics of pain in skin carcinomas
Numerical visual pain
Measured: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Evaluate characteristics of in skin carcinomas
score DN4
Measured: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Apr 2015
- Primary completion1 Apr 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290989
- Sponsor's protocol ID
- PRURITCC
- Acronym
- PRURITCC
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 25 Sep 2017
- 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 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Itch and Pain Characteristics in Skin Carcinomas
- ClinicalTrials.gov ID
- NCT03290989
- Acronym / sponsor ID
- PRURITCC / PRURITCC
- Conditions
- Skin Carcinoma, Skin Cancer, Pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 25 Sep 2017 (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.
The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From 1 April 2015 to 31 July 2015, all patients presenting with a skin lesion suspicious for carcinoma (BCC or SCC) at the Department of Dermatology of the Military Hospital in Brest were included in the study.
Key inclusion criteria (1 listed)
- all patients with suspected skin carcinoma aged 18 years or more
Key exclusion criteria (2 listed)
- age under 18 years,
- inability to complete the questionnaire because of cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate characteristics of pruritus in skin carcinomas
Time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)
Questions about characteristics
Evaluate characteristics of pruritus in skin carcinomas
Time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Numerical visual scale (EVA)
Evaluate characteristics of pruritus in skin carcinomas
Time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
5D-itch scale
Evaluate characteristics of pain in skin carcinomas
Time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Numerical visual pain
Evaluate characteristics of in skin carcinomas
Time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
score DN4
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 25 Sep 2017.
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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?
An observational study of Skin Carcinoma and Skin Cancer, run by University Hospital, Brest at 1 site in France.
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 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 25 Sep 2017. 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 France. 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?
Evaluate characteristics of pruritus in skin carcinomas (time frame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)). The study lists 5 primary outcomes in all. 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 25 Sep 2017.