Clinical trial · Interventional
Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma
Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): failure in regulatory statements
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma With a Breslow's Thickness ≥ 1mm | — | UNRESOLVED | — |
| Obstructive Sleep Apnea Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nocturnal oximetry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- screening oxymetry
- description
- nocturnal oxymetry to screen for sleep apnea
- interventionNames
- Procedure: nocturnal oximetry
Primary outcomes (1)
- 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
- description
- sleep apnea is defined witn an Apea Hypopnea Index ≥ 5
Secondary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available