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Completed

NCT Number: NCT03525665

Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression

The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.

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Key information

Conditions

Follicular Lymphoma Disease Attributes Disease Progression Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT, Trani, BT, Italy

Loading trial locations.

About this study

The study does not require any intervention on the patient, but it involves the simple collection of data that are already present in the medical record. Since this is a retrospective study, it will not require further analysis or diagnostic investigations than those already made.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with initial diagnosis of follicular lymphoma since 2001
  • Histological confirmation of follicular lymphoma, grade I, II, III according to WHO 2008 classification, at the time of initial diagnosis
  • Systemic first-line treatment with immuno-chemotherapy
  • PET availability at the time of response after first-line treatment (optional)
  • Clinical and radiological evidence of FL relapse or progression
  • Histological confirmation of relapse (strongly recommended)
  • PET availability of at the time of relapse/progression and images available for central assessment
  • Availability of clinical, laboratory and therapeutic treatment data at the time of initial diagnosis and relapse/progression
  • Follow up of at least 12 months after relapse/progression

Exclusion criteria

  • None

Treatment and study plan

Metabolic activity measured by FDG-PET

Other

To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.

Primary outcomes

  1. PFS

    Time frame: 24 months

    Progression free survival from time of relapse/progression

Secondary outcomes

  1. OS

    Time frame: 24 months

    Overall survival

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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