Biolymph - a study of the causes and biology of lymphoma
| ISRCTN | ISRCTN12948913 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12948913 |
- Submission date
- 23/03/2021
- Registration date
- 30/03/2021
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Malignant lymphomas are a diverse group of diseases where lymphatic tissue undergoes a malignant transformation to cancer cells. About 2000 new cases of malignant lymphomas are diagnosed each year in Sweden. There’s increasing awareness that lymphomas are caused by multiple genetic changes. Thanks to the rapid development of methods to genetically analyse tumours researchers now have the ability to genetically characterise the DNA in tumours of all newly diagnosed lymphoma patients at Karolinska University Hospital. By analysing tumour DNA, they aim to increase understanding of how lymphomas arise and how to best predict and treat lymphomas.
In cancer some cells break and tumour DNA enters the blood circulation as cell-free DNA. Tumour-specific genetic variants may be identified in these DNA fragments. This method (also known as liquid biopsies) has recently emerged as a very promising way to assess genetic changes in several cancer forms. Thus, this study also aims to assess the use of liquid biopsies in lymphoma and find out whether liquid biopsies can provide diagnostic information, as well as information regarding response to treatment and risk of relapse.
Who can participate?
All adult patients with a newly diagnosed lymphoma at the Karolinska University Hospital, Stockholm.
What does the study involve?
The study involves the collection of tumour material (already collected in routine clinical care), extra blood samples at diagnosis and during and after treatment, and filling in questionnaires on quality of life, fatigue and neuropathy at diagnosis and at 1,2 and 5 years after diagnosis.
What are the possible benefits and risks of participating?
Primarily, future lymphoma patients are projected to benefit from the current study, but is possible that some individual patients will benefit from knowing the genetic status of their lymphoma for example for treatment choice in a relapse setting. The risks of involvement are projected to be small as all samples are taken in planned routine clinical care, and only small amounts of additional blood samples are collected. In addition, participants will need to spend some time filling in questionnaires at diagnosis and 1, 2 and 5 years after diagnosis.
Where is the study run from?
Karolinska Institutet and Karolinska University Hospital (Stockholm)
When is the study starting and how long is it expected to run for?
February 2012 to February 2030
Who is funding the study?
The study is funded by grants from the Swedish Cancer Society, Stockholm County Council, Karolinska University Hospital, King V Jubilee Fund and Genome Medicine Sweden
Who is the main contact?
Karin Ekström Smedby
karin.ekstrom.smedby@ki.se
Contact information
Scientific
Eugeniavägen 3, 171 64 Solna
Stockholm
17174
Sweden
| Phone | +46 (0)851770000 |
|---|---|
| karin.ekstrom.smedby@ki.se |
Study information
| Study design | Prospective single-centre observational study with population-based inclusion |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN12948913_PIS.docx |
| Scientific title | Prospective study of biology, aetiology and survival in lymphoma (BioLymph) |
| Study acronym | Biolymph |
| Study objectives | The general aim of this project is to further investigate the clinical significance of different genetic alterations in lymphomas and try to identify the genetic lesions that actually drive tumour progression, influence the response to different treatment alternatives, and affect survival. Further, the project aims to evaluate the potential clinical value of liquid biopsies as a DNA source for tumour characterisation, and marker of response and relapse. |
| Ethics approval(s) | Approved 19/02/2018, addition approved 22/11/2020, regional ethics board Stockholm (regionala etikprövningsnämnden Stockholm, FE 289, Karolinska Institutet, 171 77, Stockholm, Sweden; +468 (0)524 870 00; kansli@epn.stockholm.se), ref: 2017/2538-31, 2020-05978 |
| Health condition(s) or problem(s) studied | Malignant lymphoma |
| Intervention | All newly diagnosed lymphoma patients at Karolinska University Hospital are asked to participate. Participation involves the collection of tumour material for genetic analysis (using a lymphoma panel [TWIST]), consisting of approximately 250 genes known to be frequently mutated in lymphomas. Blood samples for normal DNA will be obtained at diagnosis. Blood samples for liquid biopsies will be obtained at diagnosis, during and after treatment to assess cell-free tumour DNA. Further, participating patients will fill in questionnaires on quality of life, fatigue and neuropathy at diagnosis and after 1, 2 and 5 years. |
| Intervention type | Other |
| Primary outcome measure | Number and type of genetic driver mutations potentially relevant for diagnosis, prognosis and treatment prediction, assessed by next-generation sequencing (NGS) for each tumour case at diagnosis. |
| Secondary outcome measures | 1. Progression-free survival, assessed using data from medical records, the Swedish lymphoma register and Swedish cause-of-death register from the date of study inclusion to relapse, death or end of follow-up 2. Overall survival assessed using the Swedish cause-of-death register from the date of study inclusion to death or end of follow-up 3. Level of cell-free tumour DNA measured quantitatively using haploid genome equivalents per ml of plasma at diagnosis, after the first treatment, at interim analysis, end-of-treatment and once yearly 4. Quality of life assessed using the EORTC QLQ-30 questionnaire at diagnosis and at 1, 2 and 5 years after diagnosis |
| Overall study start date | 01/02/2012 |
| Completion date | 01/02/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | Newly diagnosed adult (aged 18 years or above) lymphoma patients |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 01/02/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Solna
Stockholm
17174
Sweden
Sponsor information
Hospital/treatment centre
Eugeniavägen 3
Solna
17176
Sweden
| Phone | +46 (0)851770000 |
|---|---|
| karin.ekstrom.smedby@ki.se | |
| Website | http://www.karolinska.se/en |
"ROR" |
https://ror.org/00m8d6786 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Other |
| Publication and dissemination plan | Current publication and dissemination plan as of 18/09/2024: Planned publications in high-impact journals. The researchers have started publishing articles based on data from the study, with many subsequent publications planned. Previous publication and dissemination plan: Planned publications in high-impact journals. The researchers expect to publish the first reports during 2025, and a study protocol during 2021. The current study protocols and statistical plans are currently only available in Swedish. |
| IPD sharing plan | All data will not be available on request (for example personal data will not be available to preserve anonymity) due to, for example, GDPR limitations and ethical consent that states that data needs to be anonymised and aggregated for sharing. The researchers will share aggregated data upon request given that necessary agreements can be obtained and national and institutional legal requirements are met. The investigator to contact for this is Prof. Karin Ekström Smedby (karin.ekstrom.smedby@ki.se). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/04/2021 | No | Yes | ||
| Other publications | proof-of-concept study | 02/06/2023 | 06/11/2023 | Yes | No |
| Protocol article | feasibility and first results | 06/07/2023 | 06/11/2023 | Yes | No |
Additional files
- ISRCTN12948913_PIS.docx
- Uploaded 06/04/2021
Editorial Notes
18/09/2024: The following changes were made:
1. The overall study end date was changed from 01/02/2026 to 01/02/2030.
2. The intention to publish date was changed from 31/12/2025 to 31/12/2027.
3. The publication and dissemination plan was updated.
06/11/2023: Publication references added.
06/04/2021: The participant information sheet has been uploaded.
25/03/2021: Trial's existence confirmed by the regional ethics board Stockholm.
