Post-transplantation Lymphoproliferative DisordersNCT02984215
aCGH Impacts Survival in Plasma Cell PTLD
An observational study of Post-transplantation Lymphoproliferative Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-transplantation Lymphoproliferative Disorders
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1990to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We conducted a retrospective analysis between 1990 and 2012 of all consecutive cases of PCM and PLL-PTLD collected in the Centre Hospitalier Lyon Sud (CHLS, 6 cases) and in Necker - Enfants Malades Hospital in Paris (4 cases). There were 4 females and 6 males. Among the 8 adults, 6 had received a kidney transplant, 1 a heart transplant and one a lung transplant. Among the 2 children, one had received a heart transplant and one an allogeneic stem cell transplantation with a matched unrelated donor. Immunosuppressive regimens were heterogeneous.
Who may be able to join
- WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders).
Who cannot join
- Other than PCM or PLL PTLD at diagnosis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier Lyon sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69126
About this study
Official title: Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome wide array-based comparative genomic hybridization (aCGH)
Measured: At diagnosis of PTLD, Day 0.
Secondary outcomes (1)
Overall survival according to aCGH complexity
Measured: Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 1990
- Primary completionJan 2012
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplantation Lymphoproliferative DisordersStudies 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
- 10 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
- NCT02984215
- Sponsor's protocol ID
- 69HCL16_0720
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT02984215
- Acronym / sponsor ID
- 69HCL16_0720
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 1990
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Dec 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.
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We conducted a retrospective analysis between 1990 and 2012 of all consecutive cases of PCM and PLL-PTLD collected in the Centre Hospitalier Lyon Sud (CHLS, 6 cases) and in Necker - Enfants Malades Hospital in Paris (4 cases). There were 4 females and 6 males. Among the 8 adults, 6 had received a kidney transplant, 1 a heart transplant and one a lung transplant. Among the 2 children, one had received a heart transplant and one an allogeneic stem cell transplantation with a matched unrelated donor. Immunosuppressive regimens were heterogeneous.
Key inclusion criteria (1 listed)
- WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders).
Key exclusion criteria (1 listed)
- Other than PCM or PLL PTLD at diagnosis
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
Genome wide array-based comparative genomic hybridization (aCGH)
Time frame: At diagnosis of PTLD, Day 0.
1 secondary outcome
Overall survival according to aCGH complexity
Time frame: Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
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 6 Dec 2016.
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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.
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 Post-transplantation Lymphoproliferative Disorders, 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 1 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 6 Dec 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?
Genome wide array-based comparative genomic hybridization (aCGH) (time frame: At diagnosis of PTLD, Day 0.). 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 6 Dec 2016.