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OpenTrials
Completed

NCT Number: NCT03137511

Optimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist

Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities.

Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues.

Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision.

The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives).

Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients").

This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher.

In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Consulting a general practitioner participating in the study,
  • Having a suspicious cutaneous lesion of melanoma according to the MG,
  • Referred to a dermatologist who agreed to participate in the study,
  • > = 18 years of age, with written informed consent,
  • Affiliated to a social security scheme

Exclusion criteria

Patients:

  • Consulting a general practitioner who does not participate in the study,
  • Having no suspect melanoma lesion according to MG,
  • Referred to the dermatologist for symptoms or pathologies unrelated to a suspicion of melanoma
  • Wishing to consult a dermatologist who refused to participate in the study,
  • Refusing the transmission by mail of 2 anonymised photos,
  • <18 years of age, or with no written informed consent.
  • Major under tutelage, under curatorship

Treatment and study plan

Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist

Other

Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist

Primary outcomes

  1. Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma

    Time frame: 12 months

    Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients:

    • referred for a suspicious lesion of melanoma by the general practitioner,
    • and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision

Secondary outcomes

  1. Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma

    Time frame: 12 months

    Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients:

    • referred for a suspicious lesion of melanoma by the general practitioner,
    • BUT NOT having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision
  2. "Non-observing" patients between the 2 randomization groups

    Time frame: 12 months

    Proportion of "non-observing" patients between the 2 randomization groups. A non-observing patient is a patient who has not consulted a dermatologist within 12 months following the prescription of his or her GP.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: OASE Melanome

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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