Non Small Cell Lung CancerNCT03199599
Prognostic PET/CT Model in Non Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer 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
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 31 Aug 2019
- 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: 150 patients with Non small cell lung cancer undergoing initial staging FDG PET/CT
Who may be able to join
- non small cell lung cancer
- initial fluorodeoxygluoces (FDG) PET/CT before treatment
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Positron Emission Tomography/Computed Tomogrpahy Model in Non Small Cell Lung Cancer
Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer
Read the detailed description
Validation on a prospective cohort of patient of a predictive model for survival based on image derived parameters
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- PET/CT, image processing, outcome
- 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.
validation of a multiparametric PET/CT prognostic model
overall survival rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Sep 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MATHIEU HATT, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199599
- Sponsor's protocol ID
- PRINCE
- Other IDs
- PRT-K15-119
- Status last verified
- Apr 2020
- First submitted
- 23 Jun 2017
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Positron Emission Tomography/Computed Tomogrpahy Model in Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03199599
- Acronym / sponsor ID
- PRINCE
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- PET/CT, image processing, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 27 Jun 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.
Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer
Detailed description
Validation on a prospective cohort of patient of a predictive model for survival based on image derived parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with Non small cell lung cancer undergoing initial staging FDG PET/CT
Key inclusion criteria (2 listed)
- non small cell lung cancer
- initial fluorodeoxygluoces (FDG) PET/CT before treatment
Key exclusion criteria (1 listed)
- none
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
validation of a multiparametric PET/CT prognostic model
Time frame: 18 months
overall survival rate
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 13 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
MATHIEU HATT, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
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 Poitiers University Hospital 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 2 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 13 Apr 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?
validation of a multiparametric PET/CT prognostic model (time frame: 18 months). 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 13 Apr 2020.