Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma (MELA-SAS)

Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk 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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea Syndrome; Melanoma With a Breslow's Thickness ≥ 1mm
• Intervention / Treatment: Procedure: nocturnal oximetry

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%.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: screening oxymetry; nocturnal oxymetry to screen for sleep apnea	Procedure: nocturnal oximetry; nocturnal oximetry for screening of sleep apnea syndrome. Patients with abnormal nocturnal oximetry will be further explored by polysomnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of metastasis confirmed by thoraco-abdominal-pelvic or cerebral CT in patients subgroups with or without sleep apnea syndrome	sleep apnea is defined witn an Apea Hypopnea Index ≥ 5	3 years period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of a positive status of the sentinel lymph node confirmed by histological measurements in patients subgroups with or without sleep apnea syndrome	sleep apnea is defined witn an Apea Hypopnea Index ≥ 5	initial care
In the subgroup of patients with sleep apnea syndrome, ratio of patients with metastatic evolution according to the CPAP treatment adherence	adherence of CPAP ≥ 4h by night or 3h by night	3 years

Collaborators and Investigators

• Sponsor: AGIR à Dom
• Investigators: Principal Investigator: Jean Louis Pépin, Pr MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Melanoma
• Other Study ID Numbers: Agiradom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO