This Study Describes the Different Causes of Death in 237 FL PatientsNCT02951871
Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis
An observational study of This Study Describes the Different Causes of Death in 237 FL Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- This Study Describes the Different Causes of Death in 237 FL Patients
- How many people
- 237 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2000to Jul 2016
- 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: This retrospective analysis was performed in 3 reference center where patients were treated and regularly followed for FL between January 2000 and December 2015. All patients were initially staged according to the conventional recommendations, including a clinical examination and blood tests, a bone marrow biopsy, and a computerized tomography body scan. The treatment modalities have evolved over time and were chosen according to the institutional guidelines.
Who may be able to join
- FL patients
- patients recorded as deceased
Who cannot join
- -Other diagnosis than FL
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier Lyon sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69126
About this study
Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.
- Keywords
- Follicular lymphoma; death, rituximab, treatment related toxicity
- Medical subject headings
- Lymphoma, Follicular, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LP: Lymphoma Progression | Not described | |
| TRM: Treatment Related Mortality | Not described | |
| NHM: Non hematologic malignancy | Not described | |
| OC: Other Cause | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: OS length was calculated from the date of diagnosis to the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2000
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Describes the Different Causes of Death in 237 FL PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Time perspective
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951871
- Sponsor's protocol ID
- 69HCL16_0719
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis
- ClinicalTrials.gov ID
- NCT02951871
- Acronym / sponsor ID
- 69HCL16_0719
- Keywords
- Follicular lymphoma; death, rituximab, treatment related toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Nov 2016 (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.
Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.
Study design
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LP: Lymphoma Progression | – | – |
| TRM: Treatment Related Mortality | – | – |
| NHM: Non hematologic malignancy | – | – |
| OC: Other Cause | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective analysis was performed in 3 reference center where patients were treated and regularly followed for FL between January 2000 and December 2015. All patients were initially staged according to the conventional recommendations, including a clinical examination and blood tests, a bone marrow biopsy, and a computerized tomography body scan. The treatment modalities have evolved over time and were chosen according to the institutional guidelines.
Key inclusion criteria (2 listed)
- FL patients
- patients recorded as deceased
Key exclusion criteria (1 listed)
- -Other diagnosis than FL
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
overall survival (OS)
Time frame: OS length was calculated from the date of diagnosis to the date of death
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 Nov 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 This Study Describes the Different Causes of Death in 237 FL Patients, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 Nov 2016. 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 France. 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?
overall survival (OS) (time frame: OS length was calculated from the date of diagnosis to the date of death). 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 Nov 2016.