Sleep Apnoea Syndrome and Hepatocellular Carcinoma

NCT04190498 | Withdrawn

• 2 other identifiers: 38RC17.4102018-A02400-55
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

Conditions

Sleep Apnea, Obstructive; Hepatocellular Carcinoma; Non Alcoholic Steato Hepatitis

Keywords

Sleep Apnea, Obstructive; Hepatocellular carcinoma; Non Alcoholic Steato Hepatitis; hepatitis C virus

Outcome Measures

Primary Outcomes (1)

• The study will compare OSA prevalence in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

  Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry

  2 years

Secondary Outcomes (20)

• The study will compare the 3% oxygen desaturation index between groups.

  2 years

• The study will compare the 2% oxygen desaturation index between groups.

  2 years

• The study will compare the 4% oxygen desaturation index between groups.

  2 years

• This study will compare the number of micro-arousals between groups.

  2 years

• This study will compare the time spent with a saturation less than 90 % between groups.

  2 years

Study Arms (2)

NASH-related HCC

The study is focused on patients suffering from NASH-induced HCC. Each patient with NASH-related HCC will be paired with 2 patients with non NASH-related HCC (HCV-induced CHC).

Diagnostic Test: Nocturnal oximetry

HCV-related HCC

HCV-related HCC has been chosen as control population for several reasons: HCV represent a common etiology of HCC; with a distinct pathophysiology distinct from that of post-NASH HCC; populations with post-NASH and post-HCV CHC share similar epidemiological characteristics.

Diagnostic Test: Nocturnal oximetry

Interventions

Nocturnal oximetry DIAGNOSTIC_TEST

Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes

HCV-related HCC; NASH-related HCC

Eligibility Criteria

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

Study Population

Patients will prospectively included in the French Liver Biobanks network - INCa, BB-0033-00085 (CRB-Foie). Patients suffering from a NASH-related or HCV-related hepatocellular carcinoma who were only treated by surgery will be selected. Each NASH-related HCC patient will be adjusted with two HCV-related HCC patients based on a propensity score according to their age range, sex, BMI, tumor stage. For each patient, the duration of the study will be 1 month maximum, with only one visit for inclusion. Survival data at 12 and 24 months will be from the medical record and will not require a visit. The total duration of study will be 48 months.

You may qualify if:

• Man and woman
• \>18 years
• Diagnosis of NASH-induced HCC or HCV-induced HCC
• Patients treated by surgical excision
• Patients not opposed to the study

You may not qualify if:

• Patient refusal
• Alcohol consumption\> 20g / day for women and\> 30g / day for men
• Patient with HCV genotype 3
• Tumor vascular invasion identified preoperatively
• Other etiologies of hepatopathies (alcoholic, viral B, autoimmune, hemochromatosis)
• Other chronic respiratory diseases: chronic obstructive pulmonary disease, respiratory insufficiency
• Patient weight variation \>5% since surgical treatment of his HCC
• Subject deprived of liberty or under guardianship

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Minovés-Kotzki

La Tronche, Rhones-Alpes, 38700, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Carcinoma, Hepatocellular; Hepatitis C

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• Jean-Louis Pépin, MD,PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Thomas Decaens, MD,PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: December 9, 2019
• Study Start: January 21, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

FR (1)