Adenocarcinoma of Lung Stage IVNCT04493827
Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center
An observational study of Adenocarcinoma of Lung Stage IV and Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung Stage IV, Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Dec 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: Patients with metastatic lung adenocarcinoma diagnosed between 2012 and 2014 with a medical follow-up entirely done in Nancy Central Hospital
Who may be able to join
- Lung adenocarcinoma
- Patients diagnosed at a metastatic stage
- Patient who benefited an oncogenic driver research on their histologic samples
- Medical follow-up entirely done in Nancy Central Hospital
Who cannot join
- Patients with double histology
- Synchronous cancer
- Patients with surgical care
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54000
About this study
The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.
- Conditions
- Adenocarcinoma of Lung Stage IV, Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic
- Medical subject headings
- Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time (in months) from anatomopathological diagnosis to death
Measured: over a period of 5 years (Day 0 = anatomopathological diagnosis)
Progression Free survival
Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria
Measured: over a period of 5 years (Day 0 = anatomopathological diagnosis)
Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma
Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas
Measured: At base line (Day 0 = anatomopathological diagnosis)
Secondary outcomes (1)
Distribution in percentage of metastasis sites according oncogenic drivers
Distribution in percentage of metastatic sites assessed by CT-scan for metastatic lung adenocarcinomas according oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2)
Measured: At baseline (Day 0 = anatomopathological diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startJan 2011
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Lung Stage IVStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelica Tiotiu, Study director, Nancy Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493827
- Sponsor's protocol ID
- 2019PI224
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center
- ClinicalTrials.gov ID
- NCT04493827
- Acronym / sponsor ID
- 2019PI224
- Conditions
- Adenocarcinoma of Lung Stage IV, Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jul 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.
The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.
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 metastatic lung adenocarcinoma diagnosed between 2012 and 2014 with a medical follow-up entirely done in Nancy Central Hospital
Key inclusion criteria (4 listed)
- Lung adenocarcinoma
- Patients diagnosed at a metastatic stage
- Patient who benefited an oncogenic driver research on their histologic samples
- Medical follow-up entirely done in Nancy Central Hospital
Key exclusion criteria (3 listed)
- Patients with double histology
- Synchronous cancer
- Patients with surgical care
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
Overall survival
Time frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)
Time (in months) from anatomopathological diagnosis to death
Progression Free survival
Time frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)
Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria
Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma
Time frame: At base line (Day 0 = anatomopathological diagnosis)
Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas
1 secondary outcome
Distribution in percentage of metastasis sites according oncogenic drivers
Time frame: At baseline (Day 0 = anatomopathological diagnosis)
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 30 Jul 2020.
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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.
Angelica Tiotiu study director
Nancy Central Hospital
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 Adenocarcinoma of Lung Stage IV and Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic, run by Central Hospital, Nancy, France 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 4 inclusion and 3 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 30 Jul 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?
Overall survival (time frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)). The study lists 3 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 30 Jul 2020.