Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01024-47 | Other Identifier | French Health Products Safety Agency |
Not provided
Not provided
Not provided
Negative interim analysis
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sivan Innovation Ltd. | INDUSTRY |
| Takeda | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard | No Intervention | Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOOVCARE | Device | web-mediated follow up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Detection Time | Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed | 24 months |
| Number of Complication Observed | Collection of all complication presented by patients |
Not provided
Inclusion Criteria:
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
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katell LE DU, MD | Centre Jean Bernard - Le Mans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHBA Vannes | Vannes | Brittany Region | 56017 | France | ||
| Institut Bergonié |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 MOOVCARE: web-mediated follow up |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2019 |
Not provided
Randomised, open, multicenter prospective trial
Not provided
Not provided
Not provided
Not provided
| 24 months |
| Rate of Hospitalization for Vital Emergency | Collection of serious adverse events | 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 | 24 months |
| Compliance | Number of assessement completed (usually 1 per 2 weeks) by patients | 24 months |
| Performances Status (PS) at Relapse | PS according to WHO | 24 months |
| Quality of Life | Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months | up to 12 months |
| Depression | Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months | up to 12 months |
| Satisfaction | Completion of a questionnaire after 6 months | 6 months |
| Progression Free Survival | Time between the diagnostic of partial or complete response and the diagnostic of relapse | 24 months |
| Overall Survival | Time between the diagnostic of partial or complete response and the patient's death | 24 months |
| Bordeaux |
| Gironde |
| 33076 |
| France |
| Polyclinique du Parc | Caen | Normandy | 14000 | France |
| Institut d'Hématologie de Basse Normandie | Caen | Normandy | 14033 | France |
| Hôpital Privé du Confluent | Nantes | Pays de Loire | 44277 | France |
| Centre Hospitalier Universitaire Jean Minjoz | Besançon | 25030 | France |
| Polyclinique Bordeaux Nord | Bordeaux | 33077 | France |
| Centre Hospitalier Univeritaire | Dijon | 21000 | France |
| CHU Grenoble | Grenoble | 38700 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| Ch Mont de Marsan | Mont-de-Marsan | 40000 | France |
| Centre d'Oncologie de Gentilly | Nancy | 54000 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Clinique Saint Anne | Strasbourg | 67000 | France |
| Centre Hospitalier Universitaire | Tours | 37044 | France |
| FG001 |
| Standard |
Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 MOOVCARE: web-mediated follow up |
| BG001 | Standard | Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The results presented are those of the interim analysis planned for the first 40 patients included. A complete analysis will be done on all the patients (52) after incrementing all the data of the patients included in a second step. | Posted | Count of Participants | Participants | 6 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Complication Detection Time | Time between the diagnosis of a complication and the nearest expected date of the subsequent follow-up programmed | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Complication Observed | Collection of all complication presented by patients | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Rate of Hospitalization for Vital Emergency | Collection of serious adverse events | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Compliance | Number of assessement completed (usually 1 per 2 weeks) by patients | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Performances Status (PS) at Relapse | PS according to WHO | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life | Completion of the quality of life questionnaire QLQ-C30 at baseline and after 3, 6, 9 and 12 months | Not Posted | up to 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Depression | Completion of the "HUMEUR PhQ9" questionnaire at baseline and after 3, 6, 9 and 12 months | Not Posted | up to 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction | Completion of a questionnaire after 6 months | Not Posted | 6 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Time between the diagnostic of partial or complete response and the diagnostic of relapse | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time between the diagnostic of partial or complete response and the patient's death | Not Posted | 24 months | Participants |
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 MOOVECARE application every 14 days to complete a questionnaire about their symptoms. Imaging will be performed in the event of an alert or clinical problem MOOVECARE: web-mediated follow up | 2 | 27 | 4 | 27 | 0 | 27 |
| EG001 | Standard | Patients will have the usual follow up (Clinical and biological exam every 3 months and imaging every 6 months) | 1 | 25 | 5 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| fever | General disorders | Systematic Assessment |
| ||
| falls | General disorders | Systematic Assessment |
| ||
| endometriel carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| pyelonephritis | Renal and urinary disorders | Systematic Assessment |
| ||
| sepsis | Infections and infestations | Systematic Assessment |
| ||
| influenza A | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katell LE DU | Weprom | 241682940 | 0033 | k.ledu@cjb72.org |
| Apr 2, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
|
|
|