Analysis of liquid biopsies to improve diagnosis and follow-up in cancer and other conditions
| ISRCTN | ISRCTN35928837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35928837 |
- Submission date
- 08/02/2025
- Registration date
- 06/06/2025
- Last edited
- 06/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Liquid biopsies (LBs) are minimally invasive samples of body fluids that contain tiny amounts of circulating tumour-derived (ct) DNA, RNA and proteins. Thanks to new, ultrasensitive techniques, LBs have emerged as a potential cancer biomarker. It has been shown that analysis of ctDNA from liquid biopsies using broad screening methods, including whole-genome or targeted gene panel sequencing, and sensitive methods that target specific genetic aberrations is possible. Further techniques are being developed for analysing all the components (including RNA and proteins) for multi-omic analysis of LBs (m-LBs), to increase sensitivity and precision. Together with the doctors involved in cancer care, the research team have identified three core clinical questions which will be used to test LBs: 1. Can LBs provide a molecular diagnosis when tissue biopsies are not available (such as some brain tumours)?; 2. Are LBs as good (or better) as current clinical tests for providing information on prognosis and risk for developing metastatic disease?; and, 3. Can LBs be successfully used to monitor therapy response and detect early relapse?
Who can participate?
Patients with cancer, risk of cancer and other somatic conditions
What does the study involve?
LBs (blood, cerebrospinal fluid when available, urine) will be collected from study participants. The analyses are performed retrospectively and will not be used in the treatment or follow-up of the participants.
What are the possible benefits and risks of participating?
There are no direct benefits to participating in this study. The aim is to improve the diagnosis and follow-up of future patients with the same condition. The risks are minor and include minor complications from taking the samples (done in conjunction with clinical sampling) and the small risk (or benefit depending on how you look at it) that a germline predisposition can be identified that would enable us to offer you more information on possible cancer risks and to refer you to an individualised risk reduction program. The samples are usually collected when other samples are collected clinically which entails minimal risks.
Where is the study run from?
Karolinska University Hospital, Sweden
When is the study starting and how long is it expected to run for?
January 2015 to December 2040
Who is funding the study?
1. The Childhood Cancer Foundation
2. The Cancer Foundation
3. Stockholm County Council
Who is the main contact?
Dr Emma Tham, emma.tham@ki.se
Contact information
Public, Scientific, Principal Investigator
Clinical Genetics and Genomics
Karolinska University Hospital
Stockholm
171 76
Sweden
 ORCID ID |
0000-0001-6079-164X |
|---|---|
| Phone | +46-12370000 |
| emma.tham@ki.se |
Study information
| Study design | Prospective multi-centre retrospective analysis. Longitudinal with comparison to standard of care performed in parallel. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Multi-omics analyses of liquid biopsies |
| Study acronym | Multi-Liq |
| Study objectives | Liquid biopsies can be used as a complement to standard-of-care methods to provide a molecular diagnosis in patients where no tumour biopsy is available and to refine risk stratification and monitoring during treatment and follow-up of cancer patients |
| Ethics approval(s) |
1. Approved 12/09/2016, Regional Ethics Review Board (Tomtebodavägen 18, Stockholm, 171 77, Sweden; +46 08-52487000; kansli@stockholm.epn.se), ref: 2016/2-31/1 2. Approved 19/01/2025, The Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46-10-475 08 00; registrator@etikprovning.se), ref: 2024-08384-02 |
| Health condition(s) or problem(s) studied | Cancer, risk of cancer and other somatic conditions |
| Intervention | The collection and analysis of liquid biopsies using various methods, mostly based on cfDNA, but also with multi-omics approaches. Comparison to diagnosis and follow-up performed within routine clinical care to evaluate the added utility of liquid biopsies. |
| Intervention type | Not Specified |
| Primary outcome measure | Additional diagnostic or prognostic information provided by liquid biopsies measured using massive parallel sequencing, methylation analysis or targeted digital PCR at diagnosis |
| Secondary outcome measures | Prognostic information and correlation to survival from liquid biopsies measured using massive parallel sequencing, epigenetic analysis, targeted digital PCR and/or proteomics at diagnosis, during or after treatment or during follow-up |
| Overall study start date | 01/01/2015 |
| Completion date | 31/12/2040 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 0 Days |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 10000 |
| Key inclusion criteria | 1. Patients with cancer of a type included in the study 2. Individuals with a predisposition for cancer 3. Individuals with other somatic conditions not classified as cancer 4. Not able to give informed consent |
| Key exclusion criteria | Not meeting the participant exclusion criteria |
| Date of first enrolment | 15/11/2016 |
| Date of final enrolment | 31/12/2035 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
17176
Sweden
Uppsala
751 85
Sweden
Sponsor information
Hospital/treatment centre
Eugeniavägen 3, Solna
Stockholm
SE-171 76
Sweden
| Phone | +46 8 123 70 000 |
|---|---|
| kontakt@regionstockholm.se | |
| Website | https://www.karolinskahospital.com |
"ROR" |
https://ror.org/00m8d6786 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Childhood Cancer Foundation
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2036 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Results will be published in scientific peer-reviewed journals |
| IPD sharing plan | All participants receive written and oral information on the study and provide written informed consent. The results from the liquid biopsy analyses and the clinical data will be stored in a non-publically available study repository (only available to the researchers involved in the project) and relevant results will be published in peer-reviewed journals |
Editorial Notes
10/02/2025: Study's existence confirmed by the Swedish Ethical Review Authority.
