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

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ClinicalTrials.gov Identifier: NCT02699918
Recruitment Status : Withdrawn (failure in regulatory statements)
First Posted : March 7, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom

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.


Condition or disease Intervention/treatment Phase
Melanoma With a Breslow's Thickness ≥ 1mm Obstructive Sleep Apnea Syndrome Procedure: nocturnal oximetry Early Phase 1

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%.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk Melanoma
Study Start Date : December 1, 2015
Estimated Primary Completion Date : April 1, 2016
Actual Study Completion Date : October 1, 2016


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.




Primary Outcome Measures :
  1. Ratio of metastasis confirmed by thoraco-abdominal-pelvic or cerebral CT in patients subgroups with or without sleep apnea syndrome [ Time Frame: 3 years period ]
    sleep apnea is defined witn an Apea Hypopnea Index ≥ 5


Secondary Outcome Measures :
  1. Ratio of a positive status of the sentinel lymph node confirmed by histological measurements in patients subgroups with or without sleep apnea syndrome [ Time Frame: initial care ]
    sleep apnea is defined witn an Apea Hypopnea Index ≥ 5

  2. In the subgroup of patients with sleep apnea syndrome, ratio of patients with metastatic evolution according to the CPAP treatment adherence [ Time Frame: 3 years ]
    adherence of CPAP ≥ 4h by night or 3h by night



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699918


Locations
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France
Grenoble University Hospital
Grenoble, France
Sponsors and Collaborators
AGIR à Dom
Investigators
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Principal Investigator: Jean Louis Pépin, Pr MD University Hospital, Grenoble

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Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT02699918     History of Changes
Other Study ID Numbers: Agiradom
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Melanoma
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases