Non Small Cell Lung CancerNCT04309422
Texture Features and PDL1 in CT-PET 18 FDG
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging. The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected. 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
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 31 Jan 2020
- 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: Adult patient with initial CT-PET 18 FDG realized in the nuclear service of Montpellier university hospital, with non small cell lung carcinoma diagnosed with biopsy of the primitive site or local drainage lymphadenopathy.
Who may be able to join
- adult patient ;
- first CT-PET 18 FDG realized for the inital staging ;
- absence of previous treatment for a thoracic neoplasm ;
- biopsy realized on the primitive site or local drainage lymphadenopathy ;
- primitive site viewable with morphological imagery ;
- availability of evaluation of PDL1's overexpression ;
Who cannot join
- Refusal to participate in this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Texture Features With CT-PET 18 FDG and Overexpression of PDL1 in Non-small-cell Lung Carcinomas During the Initial Staging.
Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging.
The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected.
84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Correlation between overexpression of PDL1, texture features, CT-PET 18 FDG, Non Small Cell Lung Carcinoma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Overexpression of PDL1 | Overexpression of PDL1 | |
| Absence of overexpression of PDL1 | Absence of overexpression of PDL1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between at least one texture feature and overexpression of PDL1
Correlation between at least one texture feature and overexpression of PDL1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Apr 2018
- Primary completion1 Oct 2018
- Study completion31 Jan 2020
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 University Hospital, MontpellierThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste MALLET, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309422
- Sponsor's protocol ID
- RECHMPL19_0623
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Texture Features With CT-PET 18 FDG and Overexpression of PDL1 in Non-small-cell Lung Carcinomas During the Initial Staging.
- ClinicalTrials.gov ID
- NCT04309422
- Acronym / sponsor ID
- RECHMPL19_0623
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Correlation between overexpression of PDL1, texture features, CT-PET 18 FDG, Non Small Cell Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 16 Mar 2020 (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.
Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging.
The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected.
84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overexpression of PDL1 | – | –Overexpression of PDL1 |
| Absence of overexpression of PDL1 | – | –Absence of overexpression of PDL1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with initial CT-PET 18 FDG realized in the nuclear service of Montpellier university hospital, with non small cell lung carcinoma diagnosed with biopsy of the primitive site or local drainage lymphadenopathy.
Key inclusion criteria (6 listed)
- adult patient ;
- first CT-PET 18 FDG realized for the inital staging ;
- absence of previous treatment for a thoracic neoplasm ;
- biopsy realized on the primitive site or local drainage lymphadenopathy ;
- primitive site viewable with morphological imagery ;
Key exclusion criteria (1 listed)
- Refusal to participate in this research
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
Correlation between at least one texture feature and overexpression of PDL1
Time frame: 1 day
Correlation between at least one texture feature and overexpression of PDL1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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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-Baptiste MALLET principal investigator
University Hospitals of Montpellier
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 University Hospital, Montpellier 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 6 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: finished, as of the sponsor's last update on 18 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between at least one texture feature and overexpression of PDL1 (time frame: 1 day). 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 18 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.