Lymphoma, T-CellNCT03154710
Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response
A study testing MOOVCARE in people with Lymphoma, T-Cell and Lymphoma, Large B-Cell, Diffuse, run by Weprom at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Hodgkin
- What is being tested?
- MOOVCARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 15 sitesFrance
- Study dates
- 12 Jul 2017to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 either:
- T-cell lymphoma in first complete or partial response
- Hodgkin lymphoma in 2nd complete or partial response including after autograft
- Large B-cell diffuse lymphoma in 2nd complete or partial response including after autograft
- End-of-treatment imaging in the last 4 weeks
- Age ≥ 18 years
Show all 11Show fewer
- PS ≤2 (WHO)
- Patient with an initial symptoms score less than or equal to 5
- Patient with internet access and mailbox
- Patient affiliated to a social security scheme
- Patient with written consent prior to any procedure specific to the study
Who cannot join
- Patient whose lymphoma progressed at the end of the specific treatment (evaluation <3 months after the end of the previous treatment)
- Symptomatic brain or meninges localisation
- 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
- Persons deprived of their liberty or under trusteeship
- 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
- Patients who can not follow the protocol for psychological, social, family or geographical reasons,
- Pregnancy or breast-feeding
- Patient participating in another interventional study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030
Institut Bergonié
Bordeaux, Gironde, 33076
Polyclinique Bordeaux Nord
Bordeaux, 33077
Polyclinique du Parc
Caen, Normandy, 14000
Institut d'Hématologie de Basse Normandie
Caen, Normandy, 14033
Centre Hospitalier Univeritaire
Dijon, 21000
CHU Grenoble
Grenoble, 38700
Centre Jean Bernard
Le Mans, 72000
Ch Mont de Marsan
Mont-de-Marsan, 40000
Centre d'Oncologie de Gentilly
Nancy, 54000
Hôpital Privé du Confluent
Nantes, Pays de Loire, 44277
Hopital Saint Louis
Paris, 75475
Clinique Saint Anne
Strasbourg, 67000
Centre Hospitalier Universitaire
Tours, 37044
CHBA Vannes
Vannes, Brittany Region, 56017
About this study
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.
Read more
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.
Read the 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.
- Being tested
- MOOVCARE
- Keywords
- Web-mediated follow up, Lymphoma, Personalized medicine
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOOVCAREDevice
web-mediated follow up
| Study group | Role | What they receive |
|---|---|---|
| Web-application follow up | Experimental | 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 Receives: Device: MOOVCARE |
| Standard | No intervention | Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up
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.
Measured: 6 months
Secondary outcomes (11)
Complication Detection Time
Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed
Measured: 24 months
Number of Complication Observed
Collection of all complication presented by patients
Measured: 24 months
Rate of Hospitalization for Vital Emergency
Collection of serious adverse events
Measured: 24 months
Sensibility of the Web-application
Number of alerts triggered by the application in relation to the results of the systematic imaging or triggered by an alert
Measured: 24 months
Compliance
Number of assessement completed (usually 1 per 2 weeks) by patients
Measured: 24 months
Performances Status (PS) at Relapse
PS according to WHO
Measured: 24 months
Quality of Life
Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months
Measured: up to 12 months
Depression
Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months
Measured: up to 12 months
Satisfaction
Completion of a questionnaire after 6 months
Measured: 6 months
Progression Free Survival
Time between the diagnostic of partial or complete response and the diagnostic of relapse
Measured: 24 months
Overall Survival
Time between the diagnostic of partial or complete response and the patient's death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start12 Jul 2017
- Primary completion14 Oct 2020
- Study completion12 Mar 2021
Why it stopped: Negative interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, T-CellStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open, multicenter prospective trial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Sivan Innovation Ltd., Takeda
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Principal investigator, Centre Jean Bernard - Le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154710
- Sponsor's protocol ID
- ILC-1-2016
- Other IDs
- 2016-A01024-47
- Status last verified
- Apr 2020
- First submitted
- 11 May 2017
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03154710
- Acronym / sponsor ID
- ILC-1-2016
- Keywords
- Web-mediated follow up, Lymphoma, Personalized medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative interim analysis
- Enrolment
- 52 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Sivan Innovation Ltd., Takeda
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open, multicenter prospective trial
| Arm | Type | Receives |
|---|---|---|
| Web-application follow up | Experimental | Device: MOOVCAREPatients 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 |
| Standard | No intervention | –Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient with either:
- End-of-treatment imaging in the last 4 weeks
- Age ≥ 18 years
- PS ≤2 (WHO)
- Patient with an initial symptoms score less than or equal to 5
Key exclusion criteria (8 listed)
- Patient whose lymphoma progressed at the end of the specific treatment (evaluation <3 months after the end of the previous treatment)
- Symptomatic brain or meninges localisation
- 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
- Persons deprived of their liberty or under trusteeship
- 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
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 |
|---|---|---|
| MOOVCAREweb-mediated follow up | Device | Web-application follow up |
Primary outcome
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.
11 secondary outcomes
Complication Detection Time
Time frame: 24 months
Number of Complication Observed
Time frame: 24 months
Rate of Hospitalization for Vital Emergency
Time frame: 24 months
Sensibility of the Web-application
Time frame: 24 months
Compliance
Time frame: 24 months
Performances Status (PS) at Relapse
Time frame: 24 months
Quality of Life
Time frame: up to 12 months
Depression
Time frame: up to 12 months
Satisfaction
Time frame: 6 months
Progression Free Survival
Time frame: 24 months
Overall Survival
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Katell LE DU, MD principal investigator
Centre Jean Bernard - Le Mans
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOOVCARE in people with Lymphoma, T-Cell and Lymphoma, Large B-Cell, Diffuse, run by Weprom at 15 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Significant Complications Detected and Confirmed by a Medical Consultation Performed Outside the Standard Follow-up (time frame: 6 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 28 Apr 2021.