NCT03290989

Brief 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. Demographics data, and histological data about skin carcinomas will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

September 14, 2017

Last Update Submit

September 18, 2017

Conditions

Skin CarcinomaSkin CancerPruritus

Outcome Measures

Primary Outcomes (5)

  • Evaluate characteristics of pruritus in skin carcinomas

    Questions about characteristics

    Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)

  • Evaluate characteristics of pruritus in skin carcinomas

    Numerical visual scale (EVA)

    Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma

  • Evaluate characteristics of pruritus in skin carcinomas

    5D-itch scale

    Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma

  • Evaluate characteristics of pain in skin carcinomas

    Numerical visual pain

    Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma

  • Evaluate characteristics of in skin carcinomas

    score DN4

    Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • all patients with suspected skin carcinoma aged 18 years or more

You may not qualify if:

  • age under 18 years,
  • inability to complete the questionnaire because of cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Skin NeoplasmsPruritus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 25, 2017

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

July 31, 2015

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

FR(1)