Non-Hodgkin LymphomaNCT02788084
Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
An observational study of Non-Hodgkin Lymphoma, run by Alberta Health Services, Calgary at 1 site in Canada.
Trial summary
1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens. 2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Jun 2021
- 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: 18 years or older with new diagnosis of B cell non Hodgkin lymphoma (NHL) with follow up occurring in Calgary undergoing chemotherapy.
Who may be able to join
- New diagnosis of B cell NHL
- Willing to have blood collected at timepoints of regularly scheduled follow up
- Formalin fixed paraffin embedded (FFPE) diagnostic specimen sufficient for further testing
Who cannot join
- Unwilling or unable to participate in follow up
Trial locations and contacts
1 site in 1 country.
About this study
- Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.
- Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements common to both FPPE and cfDNA specimens.
- Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE \& corresponding cfDNA ("FFPE-cfDNA dyads")
- Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or both) are of prognostic value after a clinical follow-up of 2 years from the time of diagnosis.
Read the detailed description
Patients with newly diagnosed B cell NHL will be identified. Samples will be cored from their diagnostic FFPE blocks and assayed to find lymphoma specific variants and immunoglobulin heavy chain gene rearrangements. Blood samples collected at baseline will be compared to see if variants and rearrangements can be detected in tumor specific DNA based on previous studies. Participant data will be collected, and clinical outcomes will be assessed to determine effect of mutation profiles on outcomes over 2 year follow up.
Blood samples will be prospectively collected at scheduled follow up and if primary objectives of this study are met, will be assessed for presence of cfDNA and impact of variation on clinical outcomes.
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Next Generation Sequencing, Cell free DNA
- Medical subject headings
- Lymphoma, Non-Hodgkin
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 |
|---|---|---|
| B cell Non-Hodgkin Lymphoma | 18 years of age or older with new diagnosis of non-Hodgkin lymphoma with FFPE specimen demonstrating enough tissue for elucidation of lymphoma specific variant and immunoglobulin clonotype, willing to provide baseline and follow up bloodwork to look for presence of variant and clonotype. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year Progression Free Survival
Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
Measured: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
2 year Overall Survival
Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
Measured: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
Occurrence of lymphoma specific mutations or detectable IgH rearrangements in circulating tumor specific DNA in blood samples at baseline
Proportion of cases of BNHL with somatic mutations or IgH gene rearrangements detectable in blood. Will be recorded in percentage, and determined at baseline.
Measured: Determined at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2019
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health Services, Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwynivere Davies, Alberta Health Services, Calgary
- Investigators
- Etienne Mahe, MD, FRCPC, Principal investigator, Calgary Laboratory Services, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788084
- Sponsor's protocol ID
- CC-16-0582
- Status last verified
- Jan 2020
- First submitted
- 25 May 2016
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
- ClinicalTrials.gov ID
- NCT02788084
- Acronym / sponsor ID
- CC-16-0582
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Next Generation Sequencing, Cell free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alberta Health Services, CalgaryUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Jun 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.
- Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.
- Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements common to both FPPE and cfDNA specimens.
- Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE \& corresponding cfDNA ("FFPE-cfDNA dyads")
- Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or both) are of prognostic value after a clinical follow-up of 2 years from the time of diagnosis.
Detailed description
Patients with newly diagnosed B cell NHL will be identified. Samples will be cored from their diagnostic FFPE blocks and assayed to find lymphoma specific variants and immunoglobulin heavy chain gene rearrangements. Blood samples collected at baseline will be compared to see if variants and rearrangements can be detected in tumor specific DNA based on previous studies. Participant data will be collected, and clinical outcomes will be assessed to determine effect of mutation profiles on outcomes over 2 year follow up.
Blood samples will be prospectively collected at scheduled follow up and if primary objectives of this study are met, will be assessed for presence of cfDNA and impact of variation on clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B cell Non-Hodgkin Lymphoma | – | –18 years of age or older with new diagnosis of non-Hodgkin lymphoma with FFPE specimen demonstrating enough tissue for elucidation of lymphoma specific variant and immunoglobulin clonotype, willing to provide baseline and follow up bloodwork to look for presence of variant and clonotype. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older with new diagnosis of B cell non Hodgkin lymphoma (NHL) with follow up occurring in Calgary undergoing chemotherapy.
Key inclusion criteria (3 listed)
- New diagnosis of B cell NHL
- Willing to have blood collected at timepoints of regularly scheduled follow up
- Formalin fixed paraffin embedded (FFPE) diagnostic specimen sufficient for further testing
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in follow up
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
2 year Progression Free Survival
Time frame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
2 year Overall Survival
Time frame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
Occurrence of lymphoma specific mutations or detectable IgH rearrangements in circulating tumor specific DNA in blood samples at baseline
Time frame: Determined at baseline
Proportion of cases of BNHL with somatic mutations or IgH gene rearrangements detectable in blood. Will be recorded in percentage, and determined at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- 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.
Etienne Mahe, MD, FRCPC principal investigator
Calgary Laboratory Services, University of Calgary
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 Non-Hodgkin Lymphoma, run by Alberta Health Services, Calgary at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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 Canada. 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?
2 year Progression Free Survival (time frame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma). 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 10 Jan 2020.