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SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse (SENTINEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02361099
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : June 29, 2020
SIVAN Innovation Ldt
Information provided by (Responsible Party):

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Monitoring by SENTINEL application Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : June 3, 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Monitoring by SENTINEL application
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.
Other: Monitoring by SENTINEL application
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
Other Name: new technology

No Intervention: Conventional Monitoring
Patients randomized to this arm will have a CT-scan every 3 months.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: 12 month ]
    The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.

  2. Depression [ Time Frame: 12 month ]
    Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.

  3. Relapse detection time [ Time Frame: 24 month ]
    The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging

  4. Performance Status (PS) [ Time Frame: 24 month ]
    Performance Status will be evaluated according to WHO recommendations.

  5. Cost of monitoring [ Time Frame: 24 month ]
    The cost of monitoring will be evaluated from the perspective of health insurance.

  6. Patient compliance [ Time Frame: 24 month ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02361099

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Centre Hospitalier Universitaire
Angers, France, 49933
Institut de Cancerologie de l'Ouest - site Paul Papin
Angers, France, 49933
Institut Sainte Catherine
Avignon, France, 84918
Centre Hospitalier Général
Chartres, France, 28018
Centre Hospitalier Départemenal
La Roche Sur Yon, France, 85925
Centre Jean Bernard
Le Mans, France, 72000
Centre Hospitalier
Le Mans, France, 72037
Centre Catherine de Sienne
Nantes, France, 44202
Institut de Cancerologie de l'Ouest - site René Gauducheau
Saint Herblain, France, 44805
Sponsors and Collaborators
SIVAN Innovation Ldt
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Principal Investigator: Fabrice DENIS, MD Centre Jean Bernard - LE MANS
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Responsible Party: Weprom Identifier: NCT02361099    
Other Study ID Numbers: WP-2018-01
2014-A00263-44 ( Other Identifier: RCB )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: January 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases