Patients at Risk for MelanomaOASE MelanomeNCT03137511
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
A study testing Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist in people with Patients at Risk for Melanoma, run by Nantes University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients at Risk for Melanoma
- What is being tested?
- Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2017to 28 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Patients at Risk for Melanoma
- Being tested
- Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
- Keywords
- Public Health, General Medicine, Dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologistOther
Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | General practitioners will be invited to screen for melanoma as part of their regular consultations.
* The MG collects relevant clinical information
* The MG takes 2 photographs of the lesion with his smartphone.
* The MG sends to the dermatologist by e-mail the 2 photographs of the lesion accompanied by relevant clinical information
* The MG calls the secretariat of the dermatologist to record the admissibility of the mail, to give the identity and the coordinates of the patient whose photos have just been sent and to obtain an appointment.
* The dermatologist proposes an appointment to the patient. Receives: Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist |
| Control group | No intervention | General practitioners will be invited to screen for melanoma as part of their regular consultations. General practitioners and dermatologists continue their practice in the usual way. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma
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
Measured: 12 months
Secondary outcomes (2)
Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma
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
Measured: 12 months
"Non-observing" patients between the 2 randomization groups
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start23 May 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
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 Patients at Risk for MelanomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization of MGs corresponding to their exercise sites
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137511
- Sponsor's protocol ID
- RC16_0033
- Acronym
- OASE Melanome
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouton C, Schmeltz H, Leveque C, Gaultier A, Quereux G, Dreno B, Nguyen JM, Rat C. Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation. BMC Health Serv Res. 2024 May 24;24(1):660. doi: 10.1186/s12913-024-11106-9.
PubMed 38783296
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03137511
- Acronym / sponsor ID
- OASE Melanome / RC16_0033
- Conditions
- Patients at Risk for Melanoma
- Keywords
- Public Health, General Medicine, Dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 2 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomization of MGs corresponding to their exercise sites
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologistGeneral practitioners will be invited to screen for melanoma as part of their regular consultations. * The MG collects relevant clinical information * The MG takes 2 photographs of the lesion with his smartphone. * The MG sends to the dermatologist by e-mail the 2 photographs of the lesion accompanied by relevant clinical information * The MG calls the secretariat of the dermatologist to record the admissibility of the mail, to give the identity and the coordinates of the patient whose photos have just been sent and to obtain an appointment. * The dermatologist proposes an appointment to the patient. |
| Control group | No intervention | –General practitioners will be invited to screen for melanoma as part of their regular consultations. General practitioners and dermatologists continue their practice in the usual way. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologistTaking photographs of suspicious lesions with his smartphone and sending them to the dermatologist | Other | Intervention group |
Primary outcome
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: 1. referred for a suspicious lesion of melanoma by the general practitioner, 2. and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision
2 secondary outcomes
Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma
Time frame: 12 months
"Non-observing" patients between the 2 randomization groups
Time frame: 12 months
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 14 Sep 2026.
- Results publication: PubMed 38783296Bouton C, Schmeltz H, Leveque C, Gaultier A, Quereux G, Dreno B, Nguyen JM, Rat C. Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation. BMC Health Serv Res. 2024 May 24;24(1):660. doi: 10.1186/s12913-024-11106-9.
- 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 Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist in people with Patients at Risk for Melanoma, run by Nantes University Hospital 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 6 inclusion and 8 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 14 Sep 2026. 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?
Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma (time frame: 12 months). 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 NCT03137511, 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 14 Sep 2026.