Malignant LymphomaLYMPHOTEP1NCT04464590
Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT
An observational study of Malignant Lymphoma and Relapsed Non Hodgkin Lymphoma, run by University Hospital, Brest.
Trial summary
In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Lymphoma, Relapsed Non Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All patients were examined every 3 to 4 months during the first two years, then every 6 months for three years, including physical examination and blood-test. One group (group 1) of patients received a systematic routine surveillance FDG PET/CT at 12 months (PET/CT1y) according to hematologist team and the other group (group 2) did not receive routine follow-up FDG PET/CT at 12 months (non PET/CT1y). None patient was symptomatic the first year. A median follow-up of 24 months at the end of treatment was required.
Who may be able to join
- first diagnosis of aggressive lymphoma, complete metabolic remission after a first-line of chemotherapy, no relapse in the first year after the end of treatment
Who cannot join
- minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent
About this study
Official title: Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT of Patients in Complete Remission of Malignant Lymphoma
In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy.
Read the detailed description
Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first Complete Remission (CR) with initial therapy. CR significantly decreases the risk of recurrence and increases survival. However, a cure is not guaranteed and approximately one third of lymphoma patients have a relapse disease.
FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to differentiate viable lymphoma and fibrosis or necrosis in residual mass.
The majority of relapses are diagnosed based on clinical symptoms reported by patients. And the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.
However, many medical centers use routine follow-up FDG PET/CT in addition to physical examination and laboratory analysis to detect subclinical relapse.
Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in the asymptomatic window.
Survival improvement for relapse detected by routine follow-up imaging is not clearly established compared to diagnosis by clinical symptoms.
Several studies tried to assess the value of follow-up FDG PET/CT but population, type, timing and duration of surveillance imaging was very heterogeneous.
- Conditions
- Malignant Lymphoma, Relapsed Non Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult, Diagnostic Imaging
- Keywords
- aggressive non-hodgkin lymphoma, hodgkin lymphoma, FDG-PET/CT, follow-up, routine surveillance
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission
detection rate of relapse at 1 year and at the end of follow-up
Measured: one day
performances FDG-PET/CT 1 year
sensitivity, sensibility, predictive negative value, predictive positive value, accuracy
Measured: one day
Secondary outcomes (1)
overall survival and progression-free survival
as the time from the end of first-line chemotherapy
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jan 2009
- Primary completion31 Dec 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- olivier delcroix, Principal investigator, CHRU Morvan BREST Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464590
- Sponsor's protocol ID
- 29BRC19.0131
- Acronym
- LYMPHOTEP1
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT of Patients in Complete Remission of Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT04464590
- Acronym / sponsor ID
- LYMPHOTEP1 / 29BRC19.0131
- Conditions
- Malignant Lymphoma, Relapsed Non Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult, Diagnostic Imaging
- Keywords
- aggressive non-hodgkin lymphoma, hodgkin lymphoma, FDG-PET/CT, follow-up, routine surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy.
Detailed description
Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first Complete Remission (CR) with initial therapy. CR significantly decreases the risk of recurrence and increases survival. However, a cure is not guaranteed and approximately one third of lymphoma patients have a relapse disease.
FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to differentiate viable lymphoma and fibrosis or necrosis in residual mass.
The majority of relapses are diagnosed based on clinical symptoms reported by patients. And the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.
However, many medical centers use routine follow-up FDG PET/CT in addition to physical examination and laboratory analysis to detect subclinical relapse.
Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in the asymptomatic window.
Survival improvement for relapse detected by routine follow-up imaging is not clearly established compared to diagnosis by clinical symptoms.
Several studies tried to assess the value of follow-up FDG PET/CT but population, type, timing and duration of surveillance imaging was very heterogeneous.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients were examined every 3 to 4 months during the first two years, then every 6 months for three years, including physical examination and blood-test. One group (group 1) of patients received a systematic routine surveillance FDG PET/CT at 12 months (PET/CT1y) according to hematologist team and the other group (group 2) did not receive routine follow-up FDG PET/CT at 12 months (non PET/CT1y). None patient was symptomatic the first year. A median follow-up of 24 months at the end of treatment was required.
Key inclusion criteria (1 listed)
- first diagnosis of aggressive lymphoma, complete metabolic remission after a first-line of chemotherapy, no relapse in the first year after the end of treatment
Key exclusion criteria (1 listed)
- minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission
Time frame: one day
detection rate of relapse at 1 year and at the end of follow-up
performances FDG-PET/CT 1 year
Time frame: one day
sensitivity, sensibility, predictive negative value, predictive positive value, accuracy
1 secondary outcome
overall survival and progression-free survival
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
olivier delcroix principal investigator
CHRU Morvan BREST Nuclear Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Lymphoma and Relapsed Non Hodgkin Lymphoma, run by University Hospital, Brest.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission (time frame: one day). The study lists 2 primary outcomes in all. 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 9 Jul 2020.