Sleep Apnea, ObstructiveECHAPSNCT04190498
Sleep Apnoea Syndrome and Hepatocellular Carcinoma
An observational study of Sleep Apnea, Obstructive and Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Hepatocellular Carcinoma, Non Alcoholic Steato Hepatitis
- What is being tested?
- Nocturnal oximetry
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2020to 12 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Sleep Apnea Syndrome in Patients With Hepatocellular Carcinoma
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.
Read the detailed description
Obstructive Sleep Apnea (OSA) is a common respiratory disease characterized by the occurrence of recurrent episodes of partial or total obstruction of the upper airway called hypopneas and apneas respectively. These episodes are associated with the repetitive occurrence of the desaturation-reoxygenation sequences, the so-called chronic intermittent hypoxia (IH) which is the major stimulus underlying main cardiovascular, metabolic consequences and pro-inflammatory state found in patients with OSA. Recent data from cohort studies have established that OSA is an even greater risk factor for cancer-related mortality. Hepatocellular carcinoma (HCC) is the second cancer related death worldwide and has an increasing impact in developed countries. The epidemic of metabolic syndrome (MS) plays a growing role in the occurrence of metabolic steatohepatitis (NASH) related HCC. Concerning transition from NASH to NASH-related HCC, neither the frequency nor the underlying mechanism are known. Very recently, a link between OSA (IH) and NASH has been highlighted. OSA and intermittent hypoxia should be a major worsening factor in a neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC in a context of NASH.
The objective is to compare the prevalence of OSA between patients with NASH-related and hepatitis C virus (HCV)-related HCC. In this type 3, cross-sectional, multicenter, national, non-randomized study patients suffering from a NASH-related or HCV-related hepatocellular carcinoma will be recruited. Investigators expect to show a higher prevalence of OSA in patients with HCC NASH-related but also a shorter overall survival. Complementary ex vivo studies on tumor samples will be conducted in order to explore the mechanisms by which OSA and IH would promote carcinogenesis
- Being tested
- Nocturnal oximetry
- Keywords
- Sleep Apnea, Obstructive, Hepatocellular carcinoma, Non Alcoholic Steato Hepatitis, hepatitis C virus
- Medical subject headings
- Sleep Apnea, Obstructive, Carcinoma, Hepatocellular, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal oximetryDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Nocturnal oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (20)
The study will compare the 3% oxygen desaturation index between groups.
3% IDO represents the number of oxygen desaturation of at least 3% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.
Measured: 2 years
The study will compare the 2% oxygen desaturation index between groups.
2% IDO represents the number of oxygen desaturation of at least 2% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.
Measured: 2 years
The study will compare the 4% oxygen desaturation index between groups.
4% IDO represents the number of oxygen desaturation of at least 4% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.
Measured: 2 years
This study will compare the number of micro-arousals between groups.
Micro-arousals associated with desaturation will be measured to characterize sleep fragmentation
Measured: 2 years
This study will compare the time spent with a saturation less than 90 % between groups.
The time spent with a saturation less than 90 % (Tsat90 in second) to characterize oxygen desaturations and OSA severity
Measured: 2 years
This study will compare the Pittsburgh Sleep Quality Index (PSQI) between groups.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. Consisting of 19 items, the PSQI measures several different aspects of sleep. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 2 years
This study will compare the Epworth Sleepiness Score between groups.
The Epworth sleepiness scale (ESS) is a self-administered questionnaire that's routinely used by doctors to assess daytime sleepiness. The person filling in the questionnaire rates how likely they are to doze off during the day in 8 different situations.The test evaluate the tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
Measured: 2 years
The study will compare the prevalence of OSA in patients with NASH-induced CHC with cirrhotic context compared to NASH-induced CHC patients without cirrhosis.
Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry in both subpopulations: cirrhotic and non-cirrhotic.
Measured: 2 years
The study will compare the NAFLD Activity Score (NAS score) between OSA and non-OSA subgroups of NASH patients.
NAFLD Activity Score includes the degree of steatosis, hepatocyte ballooning, lobular inflammation and fibrosis. Nas score is between 0 and 16.
Measured: 2 years
The study will compare the Brunt score between OSA and non-OSA subgroups of NASH patients.
The Brunt score for NASH patients is used to evaluate fibrosis stage. The score is between 1 and 4.
Measured: 2 Years
The study will compare the METAVIR score data between HCV OSA and HCV non-OSA patients.
The METAVIR score is used to evaluate fibrosis stage for HCV patients. The score is between 0 and 4.
Measured: 2 Years
The study will compare BCLC classification of HCC tumor between groups.
Tumor stage evaluated by BCLC classification scale :0,A,B,C and D values (0 for Stage 0 Very early stage, D for terminal stage)
Measured: 2 years
The study will compare HCC tumor size between each groups.
Tumor size (expressed in cm) is asociated to HCC prognostic the size of the tumor is associated with the prognosis of the HCC
Measured: 2 years
The study will compare HCC tumor differentiation degree between groups.
The tumor differentiation is classified in 3 levels: low, moderate or high level of tumor differentiation
Measured: 2 years
The study will compare vascular invasion of HCC tumor between groups.
Presence or absence of tumor vascular invasion
Measured: 2 years
The study will compare the number of satellite nodules of HCC between between groups.
Number of tumoral satellite nodules (multifocality)
Measured: 2 years
The study will compare plasma alpha fetoprotein level between groups.
Plasma alpha fetoprotein (AFP) level expressed in ng/ml
Measured: 2 years
The study will compare overall survival rate between groups.
Overall survival at 1 and 2 years will be collected.
Measured: 2 years
The study will compare tumor-free survival rate between groups.
Tumor-free survival at 1 and 2 years will be collected.
Measured: 2 years
The study will compare non-recurrence-free survival rate between groups.
Non-recurrence-free survival at 1 and 2 years will be retrospectively or prospectively collected.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start21 Jan 2020
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: the possibility of obtaining histological data is too low due to the lack of availability of biological samples
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, MD,PHD, Principal investigator, University Hospital, GrenobleThomas Decaens, MD,PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190498
- Sponsor's protocol ID
- 38RC17.410
- Other IDs
- 2018-A02400-55
- Acronym
- ECHAPS
- Status last verified
- May 2022
- First submitted
- 4 Nov 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Sleep Apnea Syndrome in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04190498
- Acronym / sponsor ID
- ECHAPS / 38RC17.410
- Keywords
- Sleep Apnea, Obstructive, Hepatocellular carcinoma, Non Alcoholic Steato Hepatitis, hepatitis C virus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the possibility of obtaining histological data is too low due to the lack of availability of biological samples
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive Sleep Apnea (OSA) is a common respiratory disease characterized by the occurrence of recurrent episodes of partial or total obstruction of the upper airway called hypopneas and apneas respectively. These episodes are associated with the repetitive occurrence of the desaturation-reoxygenation sequences, the so-called chronic intermittent hypoxia (IH) which is the major stimulus underlying main cardiovascular, metabolic consequences and pro-inflammatory state found in patients with OSA. Recent data from cohort studies have established that OSA is an even greater risk factor for cancer-related mortality. Hepatocellular carcinoma (HCC) is the second cancer related death worldwide and has an increasing impact in developed countries. The epidemic of metabolic syndrome (MS) plays a growing role in the occurrence of metabolic steatohepatitis (NASH) related HCC. Concerning transition from NASH to NASH-related HCC, neither the frequency nor the underlying mechanism are known. Very recently, a link between OSA (IH) and NASH has been highlighted. OSA and intermittent hypoxia should be a major worsening factor in a neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC in a context of NASH.
The objective is to compare the prevalence of OSA between patients with NASH-related and hepatitis C virus (HCV)-related HCC. In this type 3, cross-sectional, multicenter, national, non-randomized study patients suffering from a NASH-related or HCV-related hepatocellular carcinoma will be recruited. Investigators expect to show a higher prevalence of OSA in patients with HCC NASH-related but also a shorter overall survival. Complementary ex vivo studies on tumor samples will be conducted in order to explore the mechanisms by which OSA and IH would promote carcinogenesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NASH-related HCC | – | Diagnostic Test: Nocturnal oximetryThe 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). |
| HCV-related HCC | – | Diagnostic Test: Nocturnal oximetryHCV-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal oximetryDiagnosis 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 | Diagnostic test | HCV-related HCC, NASH-related HCC |
Primary outcome
The study will compare OSA prevalence in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.
Time frame: 2 years
Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry
20 secondary outcomes
The study will compare the 3% oxygen desaturation index between groups.
Time frame: 2 years
The study will compare the 2% oxygen desaturation index between groups.
Time frame: 2 years
The study will compare the 4% oxygen desaturation index between groups.
Time frame: 2 years
This study will compare the number of micro-arousals between groups.
Time frame: 2 years
This study will compare the time spent with a saturation less than 90 % between groups.
Time frame: 2 years
This study will compare the Pittsburgh Sleep Quality Index (PSQI) between groups.
Time frame: 2 years
This study will compare the Epworth Sleepiness Score between groups.
Time frame: 2 years
The study will compare the prevalence of OSA in patients with NASH-induced CHC with cirrhotic context compared to NASH-induced CHC patients without cirrhosis.
Time frame: 2 years
The study will compare the NAFLD Activity Score (NAS score) between OSA and non-OSA subgroups of NASH patients.
Time frame: 2 years
The study will compare the Brunt score between OSA and non-OSA subgroups of NASH patients.
Time frame: 2 Years
The study will compare the METAVIR score data between HCV OSA and HCV non-OSA patients.
Time frame: 2 Years
The study will compare BCLC classification of HCC tumor between groups.
Time frame: 2 years
The study will compare HCC tumor size between each groups.
Time frame: 2 years
The study will compare HCC tumor differentiation degree between groups.
Time frame: 2 years
The study will compare vascular invasion of HCC tumor between groups.
Time frame: 2 years
The study will compare the number of satellite nodules of HCC between between groups.
Time frame: 2 years
The study will compare plasma alpha fetoprotein level between groups.
Time frame: 2 years
The study will compare overall survival rate between groups.
Time frame: 2 years
The study will compare tumor-free survival rate between groups.
Time frame: 2 years
The study will compare non-recurrence-free survival rate between groups.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Pépin, MD,PHD principal investigator
University Hospital, Grenoble
Thomas Decaens, MD,PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will compare OSA prevalence in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.