Liver CirrhosisNCT06829290
Influence of Sarcopenia on the Course of the Diseases
An observational study of Liver Cirrhosis and Cancer, run by Universitatsmedizin Mainz - 1. Medizinische Klinik at 1 site in Germany.
Trial summary
Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Cancer, Cachexia
- What is being tested?
- Ultrasound
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to 1 Oct 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: oncological patient in the field of gastrointestinal tumors patients with liver cirrhosis patients attending the intensive care unit
Who may be able to join
- oncological patient in the field of gastrointestinal tumors
- patients with liver cirrhosis
- patients attending the intensive care unit
Who cannot join
- patients incapable of consenting
- patients with congenital muscle diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Labenz Labenz, MD contact
Germany1 site, 1 recruiting
- Recruiting
Universitatsmedizin Mainz
Mainz, Rhineland-Palatinate, 55131
Wolfgang Maximilian Kremer WMK Kremer, MD, 00496131177134, maximilian.kremer@unimedizin-mainz.de
Wolfgang Maximilian Kremer WMK Kremer, MD
About this study
Official title: Influence of Sarcopenia on the Course of the Diseases - Measured Using Ultrasound and Biochemical Markers
Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a form of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but still require further validation. In addition, serological muscle markers could support and simplify diagnostics.
The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using ultrasound and biomarkers.
Read the detailed description
Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stressors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.
Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle atrophy and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly important in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, complex equipment and procedures are required for the measurements. Furthermore, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized using sonography. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches to bedside morphometry that we use primarily.
Currently, little is known about serological muscle parameters. Measurement in the blood would be more elegant than sonographic muscle measurement. This would save additional instrumental diagnostics and still provide an impression of the musculature and thus possibly of the patient's fitness. Various biomarkers come into question for this. In particular, markers of muscle protein synthesis such as activin A/B and myostatin have already been described in individual collectives. However, biomarkers require further research, especially in various disease entities.
The investigators expect sonographic and laboratory measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results during therapy.
- Conditions
- Liver Cirrhosis, Cancer, Cachexia, Sarcopenia, Mechanical Ventilation
- Being tested
- Ultrasound
- Keywords
- sarcopenia, ultrasound
- Medical subject headings
- Liver Cirrhosis, Neoplasms, Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Sonographisch measurement of muscles Blood muscle markers
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
Number of patients with decompensation of the underlying disease (e.g. liver cirrhosis: hyropic decompensation) or hospitalisation or death
Measured: From the date of enrollment until the date of first documented complication (decopmensation, hospitalisation, death) from any cause whichever came first, assessed up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Universitatsmedizin Mainz - 1. Medizinische Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Maximilian Kremer, Universitatsmedizin Mainz - 1. Medizinische Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829290
- Sponsor's protocol ID
- 2024-17561
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make the data available accordingly in the context of publications.
Publications
Lena A, Hadzibegovic S, von Haehling S, Springer J, Coats AJ, Anker MS. Sarcopenia and cachexia in chronic diseases: from mechanisms to treatment. Pol Arch Intern Med. 2021 Dec 22;131(12):16135. doi: 10.20452/pamw.16135. Epub 2021 Nov 15.
PubMed 34775741Kremer WM, Labenz C, Kuchen R, Sagoschen I, Bodenstein M, Schreiner O, Worns MA, Sivanathan V, Weinmann A, Galle PR, Sprinzl MF. Sonographic assessment of low muscle quantity identifies mortality risk during COVID-19: a prospective single-centre study. J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):169-179. doi: 10.1002/jcsm.12862. Epub 2021 Dec 8.
PubMed 34881516Pinto Dos Santos D, Kloeckner R, Koch S, Hoppe-Lotichius M, Zoller D, Toenges G, Kremer WM, Zimmermann T, Mittler J, Lang H, Duber C, Galle PR, Weinmann A, Sprinzl MF. Sarcopenia as prognostic factor for survival after orthotopic liver transplantation. Eur J Gastroenterol Hepatol. 2020 May;32(5):626-634. doi: 10.1097/MEG.0000000000001552.
PubMed 31725030Zhang JX, Yan HT, Ding Y, Liu J, Liu S, Zu QQ, Shi HB. Low Psoas-Muscle index is associated with decreased survival in hepatocellular carcinoma treated with transarterial chemoembolization. Ann Med. 2022 Dec;54(1):1562-1569. doi: 10.1080/07853890.2022.2081872.
PubMed 35639492Hida T, Ando K, Kobayashi K, Ito K, Tsushima M, Kobayakawa T, Morozumi M, Tanaka S, Machino M, Ota K, Kanbara S, Ito S, Ishiguro N, Hasegawa Y, Imagama S. <Editors' Choice> Ultrasound measurement of thigh muscle thickness for assessment of sarcopenia. Nagoya J Med Sci. 2018 Nov;80(4):519-527. doi: 10.18999/nagjms.80.4.519.
PubMed 30587866Hari A, Berzigotti A, Stabuc B, Caglevic N. Muscle psoas indices measured by ultrasound in cirrhosis - Preliminary evaluation of sarcopenia assessment and prediction of liver decompensation and mortality. Dig Liver Dis. 2019 Nov;51(11):1502-1507. doi: 10.1016/j.dld.2019.08.017. Epub 2019 Sep 20.
PubMed 31547952Kobayashi K, Maruyama H, Kiyono S, Ogasawara S, Suzuki E, Ooka Y, Chiba T, Kato N, Yamaguchi T. Application of transcutaneous ultrasonography for the diagnosis of muscle mass loss in patients with liver cirrhosis. J Gastroenterol. 2018 May;53(5):652-659. doi: 10.1007/s00535-017-1378-2. Epub 2017 Aug 18.
PubMed 28821966Takai Y, Katsumata Y, Kawakami Y, Kanehisa H, Fukunaga T. Ultrasound method for estimating the cross-sectional area of the psoas major muscle. Med Sci Sports Exerc. 2011 Oct;43(10):2000-4. doi: 10.1249/MSS.0b013e31821994cb.
PubMed 21448087McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012.
PubMed 24737560Cawthon PM, Peters KW, Shardell MD, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Vassileva MT, Studenski SA, Alley DE. Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):567-75. doi: 10.1093/gerona/glu023.
PubMed 24737559Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
PubMed 31171417Durand F, Buyse S, Francoz C, Laouenan C, Bruno O, Belghiti J, Moreau R, Vilgrain V, Valla D. Prognostic value of muscle atrophy in cirrhosis using psoas muscle thickness on computed tomography. J Hepatol. 2014 Jun;60(6):1151-7. doi: 10.1016/j.jhep.2014.02.026. Epub 2014 Mar 6.
PubMed 24607622Benz E, Trajanoska K, Lahousse L, Schoufour JD, Terzikhan N, De Roos E, de Jonge GB, Williams R, Franco OH, Brusselle G, Rivadeneira F. Sarcopenia in COPD: a systematic review and meta-analysis. Eur Respir Rev. 2019 Nov 13;28(154):190049. doi: 10.1183/16000617.0049-2019. Print 2019 Dec 31.
PubMed 31722892Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13.
PubMed 26882087Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sarcopenia on the Course of the Diseases - Measured Using Ultrasound and Biochemical Markers
- ClinicalTrials.gov ID
- NCT06829290
- Acronym / sponsor ID
- 2024-17561
- Conditions
- Liver Cirrhosis, Cancer, Cachexia, Sarcopenia, Mechanical Ventilation
- Keywords
- sarcopenia, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitatsmedizin Mainz - 1. Medizinische KlinikUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Feb 2025 (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.
Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a form of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but still require further validation. In addition, serological muscle markers could support and simplify diagnostics.
The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using ultrasound and biomarkers.
Detailed description
Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stressors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.
Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle atrophy and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly important in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, complex equipment and procedures are required for the measurements. Furthermore, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized using sonography. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches to bedside morphometry that we use primarily.
Currently, little is known about serological muscle parameters. Measurement in the blood would be more elegant than sonographic muscle measurement. This would save additional instrumental diagnostics and still provide an impression of the musculature and thus possibly of the patient's fitness. Various biomarkers come into question for this. In particular, markers of muscle protein synthesis such as activin A/B and myostatin have already been described in individual collectives. However, biomarkers require further research, especially in various disease entities.
The investigators expect sonographic and laboratory measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results during therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oncological patient in the field of gastrointestinal tumors patients with liver cirrhosis patients attending the intensive care unit
Key inclusion criteria (3 listed)
- oncological patient in the field of gastrointestinal tumors
- patients with liver cirrhosis
- patients attending the intensive care unit
Key exclusion criteria (2 listed)
- patients incapable of consenting
- patients with congenital muscle diseases
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 |
|---|---|---|
| UltrasoundSonographisch measurement of muscles Blood muscle markers | Diagnostic test | – |
Primary outcome
Complication
Time frame: From the date of enrollment until the date of first documented complication (decopmensation, hospitalisation, death) from any cause whichever came first, assessed up to two years
Number of patients with decompensation of the underlying disease (e.g. liver cirrhosis: hyropic decompensation) or hospitalisation or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Results publication: PubMed 34775741Lena A, Hadzibegovic S, von Haehling S, Springer J, Coats AJ, Anker MS. Sarcopenia and cachexia in chronic diseases: from mechanisms to treatment. Pol Arch Intern Med. 2021 Dec 22;131(12):16135. doi: 10.20452/pamw.16135. Epub 2021 Nov 15.
- Results publication: PubMed 34881516Kremer WM, Labenz C, Kuchen R, Sagoschen I, Bodenstein M, Schreiner O, Worns MA, Sivanathan V, Weinmann A, Galle PR, Sprinzl MF. Sonographic assessment of low muscle quantity identifies mortality risk during COVID-19: a prospective single-centre study. J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):169-179. doi: 10.1002/jcsm.12862. Epub 2021 Dec 8.
- Results publication: PubMed 31725030Pinto Dos Santos D, Kloeckner R, Koch S, Hoppe-Lotichius M, Zoller D, Toenges G, Kremer WM, Zimmermann T, Mittler J, Lang H, Duber C, Galle PR, Weinmann A, Sprinzl MF. Sarcopenia as prognostic factor for survival after orthotopic liver transplantation. Eur J Gastroenterol Hepatol. 2020 May;32(5):626-634. doi: 10.1097/MEG.0000000000001552.
- Results publication: PubMed 35639492Zhang JX, Yan HT, Ding Y, Liu J, Liu S, Zu QQ, Shi HB. Low Psoas-Muscle index is associated with decreased survival in hepatocellular carcinoma treated with transarterial chemoembolization. Ann Med. 2022 Dec;54(1):1562-1569. doi: 10.1080/07853890.2022.2081872.
- Results publication: PubMed 30587866Hida T, Ando K, Kobayashi K, Ito K, Tsushima M, Kobayakawa T, Morozumi M, Tanaka S, Machino M, Ota K, Kanbara S, Ito S, Ishiguro N, Hasegawa Y, Imagama S. <Editors' Choice> Ultrasound measurement of thigh muscle thickness for assessment of sarcopenia. Nagoya J Med Sci. 2018 Nov;80(4):519-527. doi: 10.18999/nagjms.80.4.519.
- Results publication: PubMed 31547952Hari A, Berzigotti A, Stabuc B, Caglevic N. Muscle psoas indices measured by ultrasound in cirrhosis - Preliminary evaluation of sarcopenia assessment and prediction of liver decompensation and mortality. Dig Liver Dis. 2019 Nov;51(11):1502-1507. doi: 10.1016/j.dld.2019.08.017. Epub 2019 Sep 20.
- Results publication: PubMed 28821966Kobayashi K, Maruyama H, Kiyono S, Ogasawara S, Suzuki E, Ooka Y, Chiba T, Kato N, Yamaguchi T. Application of transcutaneous ultrasonography for the diagnosis of muscle mass loss in patients with liver cirrhosis. J Gastroenterol. 2018 May;53(5):652-659. doi: 10.1007/s00535-017-1378-2. Epub 2017 Aug 18.
- Results publication: PubMed 21448087Takai Y, Katsumata Y, Kawakami Y, Kanehisa H, Fukunaga T. Ultrasound method for estimating the cross-sectional area of the psoas major muscle. Med Sci Sports Exerc. 2011 Oct;43(10):2000-4. doi: 10.1249/MSS.0b013e31821994cb.
- Results publication: PubMed 24737560McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012.
- Results publication: PubMed 24737559Cawthon PM, Peters KW, Shardell MD, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Vassileva MT, Studenski SA, Alley DE. Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):567-75. doi: 10.1093/gerona/glu023.
- Results publication: PubMed 31171417Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
- Results publication: PubMed 24607622Durand F, Buyse S, Francoz C, Laouenan C, Bruno O, Belghiti J, Moreau R, Vilgrain V, Valla D. Prognostic value of muscle atrophy in cirrhosis using psoas muscle thickness on computed tomography. J Hepatol. 2014 Jun;60(6):1151-7. doi: 10.1016/j.jhep.2014.02.026. Epub 2014 Mar 6.
- Individual participant dataSharing planned: Undecided. We will make the data available accordingly in the context of publications.
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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.
Christian Labenz Labenz, MD contact
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 Liver Cirrhosis and Cancer, run by Universitatsmedizin Mainz - 1. Medizinische Klinik at 1 site in Germany.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Maximilian Kremer Kremer, MD (00496131175711, maximilian.kremer@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: From the date of enrollment until the date of first documented complication (decopmensation, hospitalisation, death) from any cause whichever came first, assessed up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829290, which also lists 18 linked publications.
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 17 Feb 2025.