Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma

NCT02699918 | Withdrawn Early Phase 1

• 1 other identifier: Agiradom
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ratio of a positive status of the sentinel lymph node confirmed by histological measurements in patients subgroups with or without sleep apnea syndrome

  initial care

• In the subgroup of patients with sleep apnea syndrome, ratio of patients with metastatic evolution according to the CPAP treatment adherence

  3 years

Study Arms (1)

screening oxymetry

EXPERIMENTAL

nocturnal oxymetry to screen for sleep apnea

Procedure: nocturnal oximetry

Interventions

nocturnal oximetry PROCEDURE

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

screening oxymetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean Louis Pépin, Pr MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: March 7, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)