Carcinoma, Non-Small-Cell LungNCT02483416
Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 36 sites in France.
Trial summary
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months. At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 30 participants
- Where
- 36 sitesFrance
- Study dates
- 19 Nov 2015to 27 Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC EGFR mutated
Who may be able to join
- Male or female patient older than 18 years. Adult patient diagnosed with stage IIIb/IV NSCLC locally advanced or metastatic, with activating mutation(s) of EGFR and who is EGFR-TKI naïve.
- Patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization.
- Out-patient. Patient having given written consent for participation in the study. Patient who is able to participate in the investigator's opinion. Patient affiliated with the French social security.
Who cannot join
- Patients participating in an interventional clinical study. Patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion.
- Patients participating in a therapeutic education program.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
CLI Dr Calabet, Oncolgie, Agen
Agen, 47000
HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence
Aix-en-Provence, 13616
CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence
Aix-en-Provence, 13617
HOP Centre Marie Curie, Onco, Arras
Arras, 62000
HOP Centre Hospitalier de Béziers, Pneumo, Béziers
Béziers, 34500
CLI Bordeaux Nord Aquitaine
Bordeaux, 33000
CLI Tivoli
Bordeaux, 33000
CH, Oncologie, Brive la Gaillarde,
Brive-la-Gaillarde, 19312
HOP Louis Pradel
Bron, 69677
CLI du Parc, Pneumo, Castelnau le Lez
Castelnau-le-Lez, 34170
Centre médical N de Pontoux, Oncologie, Chalon sur Saône
Chalon-sur-Saône, 71100
HOP de Chauny
Chauny, 02303
Centre Hospitalier Intercommunal, Oncolgie, Crétail
Créteil, 94010
HOP La Dracénie, Onco, Draguignan
Draguignan, 83300
HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo
La Roche-sur-Yon, 85925
HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay
Le Puy-en-Velay, 43000
HOP Hôpital Robert Boulin, Pneumo, Libourne
Libourne, 33500
Hopital Privé Jean Mermoz
Lyon, 69008
HOP Saint Joseph et Saint Luc, Pneumo, Lyon
Lyon, 69365
CHG, Oncologie, Meaux
Meaux, 77104
CLI Clémentville
Montpellier, 34070
HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse
Mulhouse, 68100
CTR d'Oncologie de Gentilly, Onco, Nancy
Nancy, 54100
CLI Polyclinique le Languedoc, Narbonne
Narbonne, 11100
CLI Polyclinique le Languedoc, Narbonne
Narbonne, 11108
CLI Saint-Pierre, Oncologie, Perpignan
Perpignan, 66000
CHR d'Annecy, Oncologie, Annecy
Pringy, 74374
HOP Cornouaille, Pneumo, Quimper
Quimper, 29000
CLI Les Bleuets, Pneumologie, Reims
Reims, 51100
HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin
Saint-Quentin, 02321
HOP Hôpitaux du Léman
Thonon-les-Bains, 74203
HOP HIA Saint-Anne
Toulon, 83800
CLI Pasteur
Toulouse, 31076
CLI Pasteur
Toulouse, 31300
Centre de Radiothérapie Marie Curie
Valence, 26000
HOP Nord Ouest de Villefranche, oncologie, Gleize
Villefranche-sur-Saône, 69655
About this study
Official title: Evaluation of the Impact of a Nurse-led Telephone Follow-up on Treatment Compliance of Patients Treated From a Locally Advanced or Metastatic Non-small-cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation(s).The PARTAGE Study.
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.
At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.
Read more
Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:
Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).
Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).
All the patients will be seen according to normal practice by the study medical team.
Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.
Read the detailed description
Purpose:
Study Design:
- Conditions
- Carcinoma, Non-Small-Cell Lung
- 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 |
|---|---|---|
| group 1 | Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team | |
| group 2 | Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up.
Measured: 3 months
Secondary outcomes (24)
Score (0-6) Obtained With the Girerd Questionnaire
Girerd questionnaire is a questionnaire composed of 6 binary questions (yes/no) and is used to assess treatment compliance. The final score obtained is the number of questions to which the patient responded "yes". Thus, the score ranges from 0 to 6. A patient will be classified as:
Good compliant with score = 0. Minor non-compliant with score = 1 or 2. Non-compliant with score >2.
Measured: at Day 30 (D30), Day 60 (D60) and Day 90 (D90)
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team
The cumulated dose (mg) of oral targeted therapy not taken between 2 visits is the sum of the doses (mg) of tablets not taken by the patient. The cumulated dose (mg) of oral targeted therapy not taken during the 3-month follow-up is the sum of the cumulated doses (mg) not taken between 2 visits during the 3-month follow-up.
Measured: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.
Cumulated dose of oral targeted therapy not taken due to dose reduction following decision of the medical team.
There were no participants with dose reduction hence the data is not available.
Measured: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following the medical team decision.
Measured: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.
Cumulated dose of oral targeted therapy not taken (all categories) following patient decision. Cumulated dose not taken in total is missing since no patient without therapy following patient decision
Measured: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.
Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction.
Measured: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.
Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision.
No patient without therapy following patient decision
Measured: 3 months
Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.
VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Measured: 3 months
Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0
The patients' quality of life was evaluated with the FACT-L questionnaire. This questionnaire explores 4 dimensions of well-being: physical, social and emotional. These items are completed by 9 questions specific to lung cancer. Subscale scores are added to obtain total score. Scores obtained with this questionnaire range between 0 and 136. The higher the score the better the quality of life.
Measured: Day0 (D0), Day30 (D30) and Day90 (D90)
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented
Measured: Day30 (D30), Day60 (D60) and Day90 (D90)
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented
Measured: D30, D60, D90
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented
Measured: D30, D60 and D90
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented
Measured: D30, D60 and D90
Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.
Number of participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented
Measured: D30, D60 and D90
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented
Measured: D30, D60 and D90
VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90
VAS score (0-10) for overall investigator satisfaction with the level of patient care at D90 (Overall investigator satisfaction) is presented.
VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Measured: D90
VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up)
VAS score (0-10) for overall general practitioner satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up) (Overall general practitioner satisfaction) is presented.
VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Measured: D90
VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up).
VAS score (0-10) for overall pharmacist satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up)(Overall pharmacist satisfaction) is presented.
VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.
Measured: D90
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented
Measured: D30, D60 and D90
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented
Measured: D30, D60 and D90
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
Number of calls made by the patients to their medical team during the 3-month follow-up is presented
Measured: D30, D60 and D90
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
Number of calls made by the medical team to their patient during the 3-month follow-up is presented
Measured: D30, D60 and D90
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented
Measured: D30, D60, D90
Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction.
Number of participants with Adverse events AEs, of AEs of grade ≥ 3, of serious adverse events (SAEs) related to the oral biological therapy and Number of AEs related to the oral targeted therapy which causes temporary or definitive discontinuation of the treatment or dose reduction are presented
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start19 Nov 2015
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483416
- Sponsor's protocol ID
- 1200.227
- Status last verified
- Oct 2018
- First submitted
- 9 Apr 2015
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Nurse-led Telephone Follow-up on Treatment Compliance of Patients Treated From a Locally Advanced or Metastatic Non-small-cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation(s).The PARTAGE Study.
- ClinicalTrials.gov ID
- NCT02483416
- Acronym / sponsor ID
- 1200.227
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.
At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.
Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:
Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).
Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).
All the patients will be seen according to normal practice by the study medical team.
Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.
Detailed description
Purpose:
Study Design:
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team |
| group 2 | – | –Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC EGFR mutated
Key inclusion criteria (3 listed)
- Male or female patient older than 18 years. Adult patient diagnosed with stage IIIb/IV NSCLC locally advanced or metastatic, with activating mutation(s) of EGFR and who is EGFR-TKI naïve.
- Patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization.
- Out-patient. Patient having given written consent for participation in the study. Patient who is able to participate in the investigator's opinion. Patient affiliated with the French social security.
Key exclusion criteria (2 listed)
- Patients participating in an interventional clinical study. Patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion.
- Patients participating in a therapeutic education program.
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
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
Time frame: 3 months
The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up.
24 secondary outcomes
Score (0-6) Obtained With the Girerd Questionnaire
Time frame: at Day 30 (D30), Day 60 (D60) and Day 90 (D90)
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team
Time frame: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.
Time frame: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.
Time frame: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.
Time frame: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.
Time frame: 3 months
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.
Time frame: 3 months
Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.
Time frame: 3 months
Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0
Time frame: Day0 (D0), Day30 (D30) and Day90 (D90)
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
Time frame: Day30 (D30), Day60 (D60) and Day90 (D90)
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
Time frame: D30, D60, D90
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
Time frame: D30, D60 and D90
Number of Unplanned Visits to the Investigator During the 3-month Follow-up
Time frame: D30, D60 and D90
Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.
Time frame: D30, D60 and D90
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
Time frame: D30, D60 and D90
VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90
Time frame: D90
VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up)
Time frame: D90
VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up).
Time frame: D90
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
Time frame: D30, D60 and D90
Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
Time frame: D30, D60 and D90
Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
Time frame: D30, D60 and D90
Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
Time frame: D30, D60 and D90
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
Time frame: D30, D60, D90
Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction.
Time frame: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 36 sites 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 3 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: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
Yes. Results are posted in the registry (first posted 1 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up. (time frame: 3 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 1 Mar 2019.