Clinical trial NCT02699918: Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma
Official title: Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk Melanoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Melanoma With a Breslow's Thickness ≥ 1mm
Obstructive Sleep Apnea Syndrome
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

Detailed description: Melanoma is a cutaneous cancer due to a proliferation of melanocytes. For metastatic cases the prognostic is poor (18% survival at 5 years). Few factors predict metastasis. Sleep Apnea Syndrome is involved in mechanism of carcinogenesis and aggressiveness markers of malignant cutaneous melanoma.

Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

Sample size: based on previous data from the investigators showing that 25% of patients with a Breslow's Thickness ≥ 1mm will have node or visceral metastasis. For an alpha threshold of 5% and a study power of 80%, with 5% of dropouts, with the hypothesis that 40% of apnea syndrome patients will metastasis versus 20% in the control group the study should include 83 patients in each group.

Statistical analysis: an intermediate analysis after 80 included patients will be performed. Peto method will be followed, results will be considered significant with a p≤0.001 and the study will be stopped.

Normality of data will be checked by Kurtosis and Skewness tests, variance equality will be tested with the Leven test. The significance level will be set at 5%.

Eligibility criteria: Inclusion Criteria:

* adults hospitalized in the dermatological unit for the initial consult for a melanoma with a Breslow's Thickness ≥ 1mm

Exclusion Criteria:

* pregnant women
* Institutionalized patient
* patients with metastasis in the lymph node or any organ at the time of the first consult
* patients with another neoplasia requiring treatment other than surgery in the last 5 years
* patients with creatinine above 200µmol/ml or clearance below 30ml/min

Primary outcomes:
measure: Ratio of metastasis confirmed by thoraco-abdominal-pelvic or cerebral CT in patients subgroups with or without sleep apnea syndrome
timeFrame: 3 years period
Secondary outcomes:
measure: Ratio of a positive status of the sentinel lymph node confirmed by histological measurements in patients subgroups with or without sleep apnea syndrome
timeFrame: initial care
measure: In the subgroup of patients with sleep apnea syndrome, ratio of patients with metastatic evolution according to the CPAP treatment adherence
timeFrame: 3 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Louis Pépin, Pr MD
role: PRINCIPAL_INVESTIGATOR
References: