Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03154710 |
| Other study ID # |
ILC-1-2016 |
| Secondary ID |
2016-A01024-47 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2017 |
| Est. completion date |
March 12, 2021 |
Study information
| Verified date |
April 2020 |
| Source |
Weprom |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
