NCT04464590

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

8 years

First QC Date

July 6, 2020

Last Update Submit

July 8, 2020

Conditions

Malignant LymphomaRelapsed Non Hodgkin LymphomaRelapsed Hodgkin's Disease, AdultDiagnostic Imaging

Keywords

aggressive non-hodgkin lymphomahodgkin lymphomaFDG-PET/CTfollow-uproutine surveillance

Outcome Measures

Primary Outcomes (2)

  • 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

    one day

  • performances FDG-PET/CT 1 year

    sensitivity, sensibility, predictive negative value, predictive positive value, accuracy

    one day

Secondary Outcomes (1)

  • overall survival and progression-free survival

    one day

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • olivier delcroix

    CHRU Morvan BREST Nuclear Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

January 1, 2009

Primary Completion

December 31, 2016

Study Completion

December 31, 2018

Last Updated

July 9, 2020

Record last verified: 2020-07