Clinical trial · Interventional
SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitoring by SENTINEL application | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monitoring by SENTINEL application
- description
- 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.
- interventionNames
- Other: Monitoring by SENTINEL application
- type
- NO_INTERVENTION
- label
- Conventional Monitoring
- description
- Patients randomized to this arm will have a CT-scan every 3 months.
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patient with lung cancer (NSCLC and SCLC), histologically proven
2. Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
3. Age ≥ 18 ans
4. PS ≤ 2 within 15 days before enrollment
5. Patient having:
* finished his cancer treatment in the last 3 months by:
* 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.
6. Patient with an initial SENTINEL score ≤ 6
7. Patient with internet access and an e-mail box
8. Patient affiliated to a social security scheme
9. Patient has given its written consent before any specific procedure from protocol
Exclusion Criteria:
1. Patient whose disease has progressed at the end of the specific treatment
2. Symptomatic brain metastases
3. Persons deprived of liberty or under guardianship or curators
4. 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
5. Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
6. Pregnant or breastfeeding women
7. Patient participating in another interventional studyReferences
Publications (0)
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