Hodgkin Lymphoma, AdultHODGSANCT03535948
Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy
An observational study of Hodgkin Lymphoma, Adult, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2018to Dec 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Hodgkin lymphoma patients over 60 years treated between 2000 and 2013 by chemotherapy and/or radiotherapy in two university hospitals in France
Who may be able to join
- Patients over than 60 years
- Newly diagnosed Hodgkin lymphoma
Who cannot join
- Data not available
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study
Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.
- Conditions
- Hodgkin Lymphoma, Adult
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Measured: Time between diagnosis and progression or death - up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start15 May 2018
- Primary completion30 Nov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauriane Filliatre-Clement, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535948
- Sponsor's protocol ID
- PSS2016/hodgSA-CLEMENT-F/AS
- Acronym
- HODGSA
- Status last verified
- May 2019
- First submitted
- 24 Apr 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03535948
- Acronym / sponsor ID
- HODGSA / PSS2016/hodgSA-CLEMENT-F/AS
- Conditions
- Hodgkin Lymphoma, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 May 2018 (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.
Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Hodgkin lymphoma patients over 60 years treated between 2000 and 2013 by chemotherapy and/or radiotherapy in two university hospitals in France
Key inclusion criteria (2 listed)
- Patients over than 60 years
- Newly diagnosed Hodgkin lymphoma
Key exclusion criteria (1 listed)
- Data not available
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
Progression-free survival
Time frame: Time between diagnosis and progression or death - up to 100 weeks
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Lauriane Filliatre-Clement principal investigator
CHRU Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, Adult, run by Central Hospital, Nancy, France at 2 sites 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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: Time between diagnosis and progression or death - up to 100 weeks). 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 17 Jun 2019.