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Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response

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ClinicalTrials.gov Identifier: NCT03154710
Recruitment Status : Suspended (Negative interim analysis)
First Posted : May 16, 2017
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
SIVAN Innovation
Takeda
Information provided by (Responsible Party):
Weprom

Brief Summary:

Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.

With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.

The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.

The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.

Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.

The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.


Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Hodgkin Device: SENTINEL Not Applicable

Detailed Description:

Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.

With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.

The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.

The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.

Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.

In addition, strengthened clinical follow-up may improve the early detection of relapses and also improve surveillance of all significant clinical complications commonly seen in patients with severe disease (sepsis, thromboembolism, late iatrogenics, etc.). If a benefit in survival is to be expected, it will most likely be due to the early detection of relapses and better control of recidivism through early treatment and management and the early implementation of appropriate supportive care, if only by the management of depressive symptoms, or the management of iatrogenic or other complications.

The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, open, multicenter prospective trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response (SENTINEL Lymphome)
Actual Study Start Date : July 12, 2017
Actual Primary Completion Date : October 14, 2020
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: SENTINEL
Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the SENTINEL application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem
Device: SENTINEL
web-mediated follow up

No Intervention: Standard
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months)



Primary Outcome Measures :
  1. Number of significant complications detected and confirmed by a medical consultation performed outside the standard follow-up [ Time Frame: 6 months ]
    In the experimental group, identification of the absence of alert in case of complications and in the standard arm, identification of the absence of medical consultation (referring physician) in case of complications.


Secondary Outcome Measures :
  1. Complication detection time [ Time Frame: 24 months ]
    Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed

  2. Number of complication observed [ Time Frame: 24 months ]
    Collection of all complication presented by patients

  3. Rate of hospitalization for vital emergency [ Time Frame: 24 months ]
    Collection of serious adverse events

  4. Sensibility of the web-application [ Time Frame: 24 months ]
    Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert

  5. Compliance [ Time Frame: 24 months ]
    Number of assessement completed (usually 1 per 2 weeks) by patients

  6. Performances status (PS) at relapse [ Time Frame: 24 months ]
    PS according to WHO

  7. Quality of life [ Time Frame: up to 12 months ]
    Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months

  8. Depression [ Time Frame: up to 12 months ]
    Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months

  9. Satisfaction [ Time Frame: 6 months ]
    Completion of a questionnaire after 6 months

  10. Progression free survival [ Time Frame: 24 months ]
    Time between the diagnostic of partial or complete response and the diagnostic of relapse

  11. Overall survival [ Time Frame: 24 months ]
    Time between the diagnostic of partial or complete response and the patient's death



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient with either:

    1. T-cell lymphoma in first complete or partial response
    2. Hodgkin lymphoma in 2nd complete or partial response including after autograft
    3. Large B-cell diffuse lymphoma in 2nd complete or partial response including after autograft
  2. End-of-treatment imaging in the last 4 weeks
  3. Age ≥ 18 years
  4. PS ≤2 (WHO)
  5. Patient with an initial symptoms score less than or equal to 5
  6. Patient with internet access and mailbox
  7. Patient affiliated to a social security scheme
  8. Patient with written consent prior to any procedure specific to the study

Exclusion Criteria:

  1. Patient whose lymphoma progressed at the end of the specific treatment (evaluation <3 months after the end of the previous treatment)
  2. Symptomatic brain or meninges localisation
  3. Presence or history of another cancer in the last 3 years, except skin cancers (other than melanoma), in situ cancers of the cervix or other cancers considered cured
  4. Persons deprived of their liberty or under trusteeship
  5. Dementia, mental impairment or psychiatric pathology that may compromise the informed consent of the patient and / or compliance with the protocol and follow-up of the study
  6. Patients who can not follow the protocol for psychological, social, family or geographical reasons,
  7. Pregnancy or breast-feeding
  8. 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 ClinicalTrials.gov identifier (NCT number): NCT03154710


Locations
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France
CHBA Vannes
Vannes, Bretagne, France, 56017
Institut Bergonié
Bordeaux, Gironde, France, 33076
Polyclinique du Parc
Caen, Normandie, France, 14000
Institut d'Hématologie de Basse Normandie
Caen, Normandie, France, 14033
Hôpital Privé du Confluent
Nantes, Pays De Loire, France, 44277
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France, 25030
Polyclinique Bordeaux Nord
Bordeaux, France, 33077
Centre Hospitalier Univeritaire
Dijon, France, 21000
CHU Grenoble
Grenoble, France, 38700
Centre Jean Bernard
Le Mans, France, 72000
Ch Mont de Marsan
Mont-de-Marsan, France, 40000
Centre d'Oncologie de Gentilly
Nancy, France, 54000
Hopital Saint Louis
Paris, France, 75475
Clinique Saint Anne
Strasbourg, France, 67000
Centre Hospitalier Universitaire
Tours, France, 37044
Sponsors and Collaborators
Weprom
SIVAN Innovation
Takeda
Investigators
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Principal Investigator: Katell LE DU, MD Centre Jean Bernard - Le Mans
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Responsible Party: Weprom
ClinicalTrials.gov Identifier: NCT03154710    
Other Study ID Numbers: ILC-1-2016
2016-A01024-47 ( Other Identifier: French Health Products Safety Agency )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weprom:
Web-mediated follow up
Lymphoma
Personalized medicine
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin