Chronic Hepatitis CLympho CNCT01545544
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)
An observational study of Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to Nov 2014
- 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: Adult patients with HCV infection with positive viral load and a B-cell NHL.
Who may be able to join
- Patients with evolving NHL whatever its histological type
- At diagnosis or relapse or failure previous treatments stopped over 3 months
- Patients with HCV infection with positive quantitative viral load
- 18 years or more of age
- Life expectancy greater than 6 months
- Signed and informed consent
- Benefit from social security
Who cannot join
- Active uncontrolled infection (out hepatitis C)
- HIV (Human immunodeficiency virus) infection
- Severe psychiatric history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.
Read the detailed description
Main objectives are:
- Description of the clinical and histological characteristics, treatment and evolution of these NHL.
- Study their physiopathology by immunological, virologic and molecular studies.
The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.
The enrolment period is 6 years and the total study lasts 8 years.
- "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
- "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.
The enrollment is estimated at 140 patients.
- Conditions
- Chronic Hepatitis C
- Keywords
- B-Cell Non Hodgkin Lymphomas, Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics
Measured: at the first visit (Day 0)
Secondary outcomes (3)
Summary of intercurrents biological and clinical events
Measured: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
virological response
HCV quantitative viral load
Measured: Month 60
haematological response
to evaluate the correlation between hematological and virological response
Measured: Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startNov 2006
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Case only
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olivier HERMINE, PU-PH, Principal investigator, Hôpital Necker (Paris 15è), Service d'hématologieFabrice CARRAT, PU-PH, Study chair, Unité INSERM 707
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545544
- Sponsor's protocol ID
- ANRS HC13 Lympho C
- Acronym
- Lympho C
- Status last verified
- Jun 2013
- First submitted
- 21 Feb 2012
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Beral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.
PubMed 25417909
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT01545544
- Acronym / sponsor ID
- Lympho C / ANRS HC13 Lympho C
- Conditions
- Chronic Hepatitis C
- Keywords
- B-Cell Non Hodgkin Lymphomas, Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Nov 2006
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 6 Mar 2012 (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.
An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.
Detailed description
Main objectives are:
- Description of the clinical and histological characteristics, treatment and evolution of these NHL.
- Study their physiopathology by immunological, virologic and molecular studies.
The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.
The enrolment period is 6 years and the total study lasts 8 years.
- "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
- "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.
The enrollment is estimated at 140 patients.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with HCV infection with positive viral load and a B-cell NHL.
Key inclusion criteria (7 listed)
- Patients with evolving NHL whatever its histological type
- At diagnosis or relapse or failure previous treatments stopped over 3 months
- Patients with HCV infection with positive quantitative viral load
- 18 years or more of age
- Life expectancy greater than 6 months
Key exclusion criteria (3 listed)
- Active uncontrolled infection (out hepatitis C)
- HIV (Human immunodeficiency virus) infection
- Severe psychiatric history
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
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
Time frame: at the first visit (Day 0)
the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics
3 secondary outcomes
Summary of intercurrents biological and clinical events
Time frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
virological response
Time frame: Month 60
haematological response
Time frame: Month 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Derived from this study: PubMed 25417909Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Beral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.
- Related InfoLink provided by the sponsor.
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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.
Olivier HERMINE, PU-PH principal investigator
Hôpital Necker (Paris 15è), Service d'hématologie
Fabrice CARRAT, PU-PH study chair
Unité INSERM 707
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 Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases 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 7 inclusion and 3 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 7 Feb 2014. 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?
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?
presentation of NHL and HCV infection, and treatments of NHL and HCV infection (time frame: at the first visit (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545544, which also lists 1 linked publication.
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 7 Feb 2014.