Non-small Cell Lung CancerTENNCT05537701
Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
An observational study of Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC. Secondary objectives are: to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population; to investigate the correlation between T-Eos and overall \& disease-free survival; to investigate the… 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
- 316 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2022to 31 Mar 2027
- How long will I take part?
- 5 Years
- 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 resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue for analysis will be included.
Who may be able to join
- Resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue
Who cannot join
- Inclusion in a clinical study contraindicating enrollment in the present study
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC.
Secondary objectives are:
- to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population;
- to investigate the correlation between T-Eos and overall \& disease-free survival;
- to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification
Measured: October 2022
Secondary outcomes (3)
to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population
Tissue and blood eosinophil correlation
Measured: December 2022
to investigate the correlation between T-Eos and overall & disease-free survival
overall and disease-free survival
Measured: December 2022
to investigate the localization of T-Eos (periphery vs. center of the tumor lesions)
tissue eosinophil localisation
Measured: December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start3 Oct 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 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.
- 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
- 316 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sibille, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537701
- Sponsor's protocol ID
- 2022/158
- Acronym
- TEN
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2022
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
- ClinicalTrials.gov ID
- NCT05537701
- Acronym / sponsor ID
- TEN / 2022/158
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Sep 2022 (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 primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC.
Secondary objectives are:
- to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population;
- to investigate the correlation between T-Eos and overall \& disease-free survival;
- to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue for analysis will be included.
Key inclusion criteria (1 listed)
- Resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue
Key exclusion criteria (1 listed)
- Inclusion in a clinical study contraindicating enrollment in the present study
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
Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification
Time frame: October 2022
3 secondary outcomes
to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population
Time frame: December 2022
to investigate the correlation between T-Eos and overall & disease-free survival
Time frame: December 2022
to investigate the localization of T-Eos (periphery vs. center of the tumor lesions)
Time frame: December 2022
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 16 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 1 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 16 Jan 2024. 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 Belgium. 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?
Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification (time frame: October 2022). 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 16 Jan 2024.