Non Small Cell Lung CancerSARCLUNGNCT06808113
Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC
An observational study of Non Small Cell Lung Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2022to Aug 2027
- 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: Patients with NSCLC diagnosis in advanced stage, who are eligibble to receive a treatment with single-agent immunotherapy, or a chemo-immunotherapy combination
Who may be able to join
- Patients with NSCLC in advanced stage (IIIB, IV)
- Patients eligible for the treatment with single-agent immunotherapy (Pembrolizumab), or a chemo-immunotherapy combination among the approved ones for I line
- Obtainment of the informations related to medical history and the possibility to have an adequate follow up
- Obtainment of the informed consent
- Age ≥ 18 years
Who cannot join
- Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Circulating and Molecular Markers Functionally Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With Advanced Non-small Cell Lung Cancer (NSCLC).
The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.
Read the detailed description
The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone.
In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied.
Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, sarcopenia, cachexia, anorexia
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sarcopenia, Cachexia, Anorexia
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC
To determine the plasma levels of GDF15, FGF21, some microRNAs involved in inflammatory processes called inflammamiR and to perform the measurement of telomere length in leukocytes in plasma samples of patients with NSCLC before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. The association between variables of clinical interest and plasma levels of the aforementioned molecules will be evaluated. In particular, the association between their plasma levels and body composition expressed as a percentage of fat mass and lean mass and overall-survival (OS) and progression-free survival (PFS) will be evaluated.
Measured: The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared
Secondary outcomes (1)
Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC.
The leukocyte subpopulations of interest (cell. T naïve, cell. T of the central memory, cell. T of effector memory, cell. Suppressive Myeloids, cell. NK) will be reported as percentages per sample.
The association between variables of clinical interest and the percentage of different leukocyte subpopulations will be evaluated.
The association between percentages of white blood cell subpopulations and OS, PFS will be evaluated.
Measured: The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start7 Nov 2022
- Primary completion7 Oct 2024
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Ardizzoni, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808113
- Sponsor's protocol ID
- SARCLUNG
- Other IDs
- 2021.0156
- Acronym
- SARCLUNG
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating and Molecular Markers Functionally Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With Advanced Non-small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT06808113
- Acronym / sponsor ID
- SARCLUNG / SARCLUNG
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, sarcopenia, cachexia, anorexia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 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.
The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.
Detailed description
The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone.
In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied.
Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC diagnosis in advanced stage, who are eligibble to receive a treatment with single-agent immunotherapy, or a chemo-immunotherapy combination
Key inclusion criteria (5 listed)
- Patients with NSCLC in advanced stage (IIIB, IV)
- Patients eligible for the treatment with single-agent immunotherapy (Pembrolizumab), or a chemo-immunotherapy combination among the approved ones for I line
- Obtainment of the informations related to medical history and the possibility to have an adequate follow up
- Obtainment of the informed consent
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC
Time frame: The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared
To determine the plasma levels of GDF15, FGF21, some microRNAs involved in inflammatory processes called inflammamiR and to perform the measurement of telomere length in leukocytes in plasma samples of patients with NSCLC before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. The association between variables of clinical interest and plasma levels of the aforementioned molecules will be evaluated. In particular, the association between their plasma levels and body composition expressed as a percentage of fat mass and lean mass and overall-survival (OS) and progression-free survival (PFS) will be evaluated.
1 secondary outcome
Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC.
Time frame: The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared.
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 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Andrea Ardizzoni, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Non Small Cell Lung Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 5 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 Italy. 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?
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?
Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC (time frame: The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared). 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 5 Feb 2025.