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

April 2, 2021 updated by: Weprom

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire Jean MINJOZ
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord
      • Dijon, France, 21000
        • Centre Hospitalier Univeritaire
      • Grenoble, France, 38700
        • CHU Grenoble
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Mont-de-Marsan, France, 40000
        • CH Mont de Marsan
      • Nancy, France, 54000
        • Centre d'oncologie de Gentilly
      • Paris, France, 75475
        • Hopital Saint Louis
      • Strasbourg, France, 67000
        • Clinique Saint Anne
      • Tours, France, 37044
        • Centre Hospitalier Universitaire
    • Bretagne
      • Vannes, Bretagne, France, 56017
        • CHBA Vannes
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Institut Bergonie
    • Normandie
      • Caen, Normandie, France, 14000
        • Polyclinique du Parc
      • Caen, Normandie, France, 14033
        • Institut d'Hématologie de Basse Normandie
    • Pays De Loire
      • Nantes, Pays De Loire, France, 44277
        • Hôpital Privé du Confluent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Web-application follow up
Patients will have a clinical and biological exam every 3 months and a web-mediated follow up. Patients will have to connect to the MOOVCARE 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: MOOVCARE
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 months
Number of Complication Observed
Time Frame: 24 months
Collection of all complication presented by patients
24 months
Rate of Hospitalization for Vital Emergency
Time Frame: 24 months
Collection of serious adverse events
24 months
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
24 months
Compliance
Time Frame: 24 months
Number of assessement completed (usually 1 per 2 weeks) by patients
24 months
Performances Status (PS) at Relapse
Time Frame: 24 months
PS according to WHO
24 months
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
up to 12 months
Depression
Time Frame: up to 12 months
Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
up to 12 months
Satisfaction
Time Frame: 6 months
Completion of a questionnaire after 6 months
6 months
Progression Free Survival
Time Frame: 24 months
Time between the diagnostic of partial or complete response and the diagnostic of relapse
24 months
Overall Survival
Time Frame: 24 months
Time between the diagnostic of partial or complete response and the patient's death
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weprom

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda
SIVAN Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katell LE DU, MD, Centre Jean Bernard - LE MANS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILC-1-2016
  • 2016-A01024-47 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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