Carcinoma, Non-Small-Cell LungNCT03078959
Prognostic Value of PD-L1 in NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by Fondazione Ricerca Traslazionale.
Trial summary
This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- immunohistochemistry
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2017to 15 Apr 2017
- 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: 350 patients with stagi I-III NSCLC
Who may be able to join
- Early stage treatment-naive NSCLC
Who cannot join
- Received any pre-surgical treatment
- no OS data available
About this study
Official title: The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer
This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC).
Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or >50% of tumor cells express the ligand.
The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- immunohistochemistry
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistryOther
Samples will be stained using the SP263 antibody clone against PD-L1
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression
The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC
Measured: 15 days
Prognostic value
The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start3 Mar 2017
- Primary completion30 Mar 2017 (estimated)
- Study completion15 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca Traslazionale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078959
- Sponsor's protocol ID
- L3P1490
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 14 Mar 2017
- 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 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03078959
- Acronym / sponsor ID
- L3P1490
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Fondazione Ricerca TraslazionaleUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 30 Mar 2017 (estimated)
- Study completion
- 15 Apr 2017 (estimated)
- First posted
- 14 Mar 2017 (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.
This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC).
Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or >50% of tumor cells express the ligand.
The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.
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
- 350 patients with stagi I-III NSCLC
Key inclusion criteria (1 listed)
- Early stage treatment-naive NSCLC
Key exclusion criteria (2 listed)
- Received any pre-surgical treatment
- no OS data available
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 |
|---|---|---|
| immunohistochemistrySamples will be stained using the SP263 antibody clone against PD-L1 | Other | – |
Primary outcome
Expression
Time frame: 15 days
The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC
Prognostic value
Time frame: 15 days
The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Fondazione Ricerca Traslazionale.
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 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: status not confirmed, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Expression (time frame: 15 days). The study lists 2 primary outcomes in all. 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 14 Mar 2017; AzTrials last refreshed its copy on 26 Oct 2026.