Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

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.

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.

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

Cluster randomization of MGs corresponding to their exercise sites

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

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

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. BUT NOT having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision

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.

Nantes University Hospital

Patients assessed at high risk according to the SAMScore

SAMScore questionnaire

Jean-Michel NGUYEN, Doctor

Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.

Anti-Infective Agents

Respiratory System Agents

All Drugs and Chemicals

Herbal and Botanical

Acetylcysteine

N-monoacetylcystine

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

Tomato

Patients receiving NAC (N-acetylcysteine)

Participants not receiving NAC (N-acetylcysteine)

N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

N-acetylcysteine

Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Placebo arm

Douglas Grossman, MD, PhD

This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.

Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.

Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi

University of Utah

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Patients Receiving N-acetylcysteine

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

Placebo Group

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Kimberlee Taylor

UV Irradiated

Unirradiated

One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.

UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi

GCLM Biomarker

SLC1A4 Biomarker

SLC7A11 Biomarker

One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT03137511	Patients at Ris...	Taking photogra...	18 Years -	Nantes University Hospital
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	NCT03137511	Patients at Ris...	Taking photogra...	18 Years -	Nantes University Hospital
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma	NCT01610531	Patients at Ris...	SAMScore questi...	18 Years -	Nantes University Hospital
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo	NCT01612221	Patients at Ris...	N-acetylcystein... Placebo arm	18 Years -	University of Utah

Spots Global Cancer Trial Database for patients at risk for melanoma