Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation ClassificationNCT01248000
The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy
An observational study of Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification
- What is being tested?
- FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to May 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.
Who may be able to join
- Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
- Clinical stage I-IV.
- No previous chemotherapy, radiotherapy or other investigational drug for HL.
Who cannot join
- 1. None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the "Real World": a Population Based Study From Northern Italy
Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.
- Being tested
- FDG-PET
- Keywords
- Hodgkin lymphoma, FDG-PET, prognostic factor, clinical trial
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETProcedure or surgery
PET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008)
| Study group | Role | What they receive |
|---|---|---|
| classical Hodgkin lymphoma | All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study. Receives: Procedure: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: within 1 month after end of treatment
Overall survival
Measured: within 1 month after end of treatment
Disease-free survival
Measured: within 1 month after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation ClassificationStudies of the same condition, open and under way.
- 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Collaborators
- Registro Tumori di Modena, Registro Tumori di Reggio Emilia, Registro Tumori di Parma, registro Tumori di Ferrara
- Investigators
- Massimo Federico, MD, Study chair, Università di Modena e Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248000
- Sponsor's protocol ID
- PET-LH
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the "Real World": a Population Based Study From Northern Italy
- ClinicalTrials.gov ID
- NCT01248000
- Acronym / sponsor ID
- PET-LH
- Keywords
- Hodgkin lymphoma, FDG-PET, prognostic factor, clinical trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Collaborators
- Registro Tumori di Modena, Registro Tumori di Reggio Emilia, Registro Tumori di Parma, registro Tumori di Ferrara
- Study start
- May 2009
- Study completion
- May 2010 (actual)
- First posted
- 25 Nov 2010 (estimated)
- 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.
Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| classical Hodgkin lymphoma | – | Procedure: FDG-PETAll cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.
Key inclusion criteria (3 listed)
- Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
- Clinical stage I-IV.
- No previous chemotherapy, radiotherapy or other investigational drug for HL.
Key exclusion criteria (1 listed)
- 1. None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PETPET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008) | Procedure or surgery | classical Hodgkin lymphoma |
Primary outcome
Progression-free survival
Time frame: within 1 month after end of treatment
Overall survival
Time frame: within 1 month after end of treatment
Disease-free survival
Time frame: within 1 month after end of treatment
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 25 Nov 2010.
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.
Massimo Federico, MD study chair
Università di Modena e Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 3 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Progression-free survival (time frame: within 1 month after end of treatment). The study lists 3 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 25 Nov 2010.