Lung CancerPhase 3SENTINELNCT02361099
SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse
A Phase 3 study testing Monitoring by SENTINEL application in people with Lung Cancer, run by Weprom at 9 sites in France.
Trial summary
This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Monitoring by SENTINEL application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 9 sitesFrance
- Study dates
- 3 Jun 2014to Mar 2018
- Phase
- Phase 3
- 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
Who may be able to join
- Patient with lung cancer (NSCLC and SCLC), histologically proven
- Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
- Age ≥ 18 ans
- PS ≤ 2 within 15 days before enrollment
- Patient having:
- finished his cancer treatment in the last 3 months by:
Show all 16Show fewer
- Surgery or
- Surgery then adjuvant chemotherapy or
- Concomitant radio-chemotherapy or
- Conventional or stereotactic radiotherapy or
- 1st or 2nd line chemotherapy
- treatment with TKI (tyrosine kinase inhibitor) in 1st or 2nd line or maintenance treatment with Alimta® and / or Avastin® or Gemzar® well tolerated (SENTINEL 's score with this treatment (TKI or maintenance) to its latest assessment.
- Patient with an initial SENTINEL score ≤ 6
- Patient with internet access and an e-mail box
- Patient affiliated to a social security scheme
- Patient has given its written consent before any specific procedure from protocol
Who cannot join
- Patient whose disease has progressed at the end of the specific treatment
- Symptomatic brain metastases
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric pathology that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
- Pregnant or breastfeeding women
- Patient participating in another interventional study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Hospitalier Universitaire
Angers, 49933
Institut de Cancerologie de l'Ouest - site Paul Papin
Angers, 49933
Institut Sainte Catherine
Avignon, 84918
Centre Hospitalier Général
Chartres, 28018
Centre Hospitalier Départemenal
La Roche-sur-Yon, 85925
Centre Jean Bernard
Le Mans, 72000
Centre Hospitalier
Le Mans, 72037
Centre Catherine de Sienne
Nantes, 44202
Institut de Cancerologie de l'Ouest - site René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)
This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.
Read the detailed description
With a 5-year survival of about 15% pulmonary cancer is very poor prognosis. About 70 to 75% of cancers are diagnosed at advanced stages. Relapses are common and rarely curable. At least 75% of relapses are symptomatic and there is no standard monitoring after curative treatment or not. Currently, the most common monitoring strategy involves the completion of a clinical examination every 3 to 6 months associated with chest X-ray or CT-scan.
An intensive clinical and imaging monitoring has not yet shown any survival advantage but monitoring of symptoms appears to have a significant medical and economic advantage compared to imaging monitoring. This non-personalized approach is a source of anxiety for patients, especially with the approach of the date of the imaging assessment. In contrast, this monitoring can leave symptomatic patients with untreated relapse for several weeks because many symptomatic patients wait the date of the imaging assessment to consult.
the investigators have developed a score based on the dynamics and the association of clinical signs to alert the physician to a possible recurrence of lung cancer. The referring physician is alerted so early and convenes the patient for a checkup. One of the explanations which could demonstrate the gain in survival is the possibility offered by the application SENTINEL is to treat the relapses earlier, thus avoiding to wait a too much important deterioration of general condition between two monitoring follow-up more or less spaced.
- Conditions
- Lung Cancer
- Being tested
- Monitoring by SENTINEL application
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by SENTINEL applicationOther
Also called new technology
Patients will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application
| Study group | Role | What they receive |
|---|---|---|
| Monitoring by SENTINEL application | Experimental | Patients randomized to this arm will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application. Receives: Other: Monitoring by SENTINEL application |
| Conventional Monitoring | No intervention | Patients randomized to this arm will have a CT-scan every 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the period between the date of randomization to the date of death from any cause. We will also evaluate in this context the overall survival defined between the date of diagnosis and date of death whatever the cause in order to know more precisely the duration of the disease.
Measured: 24 months
Secondary outcomes (6)
Quality of Life (QOL)
The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.
Measured: 12 month
Depression
Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.
Measured: 12 month
Relapse detection time
The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging
Measured: 24 month
Performance Status (PS)
Performance Status will be evaluated according to WHO recommendations.
Measured: 24 month
Cost of monitoring
The cost of monitoring will be evaluated from the perspective of health insurance.
Measured: 24 month
Patient compliance
Patient compliance to the use of SENTINEL application will be evaluated according to the number of assessments completed (usually 1 per week) compared to the theoretical maximum number filling weekly and monthly the application over time.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start3 Jun 2014
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Sivan Innovation Ltd.
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, MD, Principal investigator, Centre Jean Bernard - LE MANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361099
- Sponsor's protocol ID
- WP-2018-01
- Other IDs
- 2014-A00263-44
- Acronym
- SENTINEL
- Status last verified
- Jan 2018
- First submitted
- 3 Feb 2015
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)
- ClinicalTrials.gov ID
- NCT02361099
- Acronym / sponsor ID
- SENTINEL / WP-2018-01
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Sivan Innovation Ltd.
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Feb 2015 (estimated)
- 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 a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.
Detailed description
With a 5-year survival of about 15% pulmonary cancer is very poor prognosis. About 70 to 75% of cancers are diagnosed at advanced stages. Relapses are common and rarely curable. At least 75% of relapses are symptomatic and there is no standard monitoring after curative treatment or not. Currently, the most common monitoring strategy involves the completion of a clinical examination every 3 to 6 months associated with chest X-ray or CT-scan.
An intensive clinical and imaging monitoring has not yet shown any survival advantage but monitoring of symptoms appears to have a significant medical and economic advantage compared to imaging monitoring. This non-personalized approach is a source of anxiety for patients, especially with the approach of the date of the imaging assessment. In contrast, this monitoring can leave symptomatic patients with untreated relapse for several weeks because many symptomatic patients wait the date of the imaging assessment to consult.
the investigators have developed a score based on the dynamics and the association of clinical signs to alert the physician to a possible recurrence of lung cancer. The referring physician is alerted so early and convenes the patient for a checkup. One of the explanations which could demonstrate the gain in survival is the possibility offered by the application SENTINEL is to treat the relapses earlier, thus avoiding to wait a too much important deterioration of general condition between two monitoring follow-up more or less spaced.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring by SENTINEL application | Experimental | Other: Monitoring by SENTINEL applicationPatients randomized to this arm will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application. |
| Conventional Monitoring | No intervention | –Patients randomized to this arm will have a CT-scan every 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient with lung cancer (NSCLC and SCLC), histologically proven
- Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
- Age ≥ 18 ans
- PS ≤ 2 within 15 days before enrollment
- Patient having:
Key exclusion criteria (7 listed)
- Patient whose disease has progressed at the end of the specific treatment
- Symptomatic brain metastases
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric pathology that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
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 |
|---|---|---|
| Monitoring by SENTINEL applicationAlso: new technologyPatients will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application | Other | Monitoring by SENTINEL application |
Primary outcome
Overall Survival (OS)
Time frame: 24 months
Overall survival is defined as the period between the date of randomization to the date of death from any cause. We will also evaluate in this context the overall survival defined between the date of diagnosis and date of death whatever the cause in order to know more precisely the duration of the disease.
6 secondary outcomes
Quality of Life (QOL)
Time frame: 12 month
Depression
Time frame: 12 month
Relapse detection time
Time frame: 24 month
Performance Status (PS)
Time frame: 24 month
Cost of monitoring
Time frame: 24 month
Patient compliance
Time frame: 24 month
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 29 Jun 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.
Fabrice DENIS, MD principal investigator
Centre Jean Bernard - LE MANS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monitoring by SENTINEL application in people with Lung Cancer, run by Weprom at 9 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 16 inclusion and 7 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 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (OS) (time frame: 24 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 29 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.