Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma

NCT ID: NCT02699918

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2016-10-01

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%.

Conditions

Melanoma With a Breslow's Thickness ≥ 1mm; Obstructive Sleep Apnea Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

screening oxymetry

nocturnal oxymetry to screen for sleep apnea

Group Type: EXPERIMENTAL

nocturnal oximetry

Intervention Type: PROCEDURE

nocturnal oximetry for screening of sleep apnea syndrome. Patients with abnormal nocturnal oximetry will be further explored by polysomnography.

Interventions

nocturnal oximetry

nocturnal oximetry for screening of sleep apnea syndrome. Patients with abnormal nocturnal oximetry will be further explored by polysomnography.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGIR à Dom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Louis Pépin, Pr MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble University Hospital

Grenoble, , France

Countries

France

Other Identifiers

Agiradom

Identifier Type: -

Identifier Source: org_study_id