To set up a biobank of prospectively collected tumor samples for genetic and immunological analysis, prior to and during IMA treatment.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the evaluation of the interaction between genetic
and immunological characteristics of a patients tumor and the IMA prescribed.
Secondary outcome
Secondary endpoint includes the determination of immunological and genetic
differences in tumor biopsies of patients responding and patients not
responding to IMA.
Background summary
In treatment of solid tumors in oncology, immune modulating agents (IMAs) have
become key players. However, only the minority of (thoracic) cancer patients
benefits and immune related toxicities can be the harmful consequences of these
agents. Reliable biomarkers are therefore urgently needed to guide personalized
treatment selection and provide on-treatment indicators. Furthermore, the
effects of IMAs on the immune system and on the tumor cells are largely
unexplained. Our aim is twofold: first we aim to map the immunological and
genetic background of the tumors of patients we plan to treat with IMAs.
Second, we aim to sequentially monitor the effects of IMAs on the immunological
and genetic characteristics of the tumor and the tumor immune microenvironment
(TME).
Study objective
To set up a biobank of prospectively collected tumor samples for genetic and
immunological analysis, prior to and during IMA treatment.
Study design
This is a biobank study that will prospectively collect tumor samples. Tumor
samples will be collected before, during and upon progression or regression of
disease to treatment.
Study burden and risks
The risks associated with tumor biopsies are low to moderate, considering the
fact that only easy accessible tumors or metastases will be biopsied.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Histological or cytological proven solid tumor
• Age >=18 years
• Written informed consent
• Performance score: WHO 0-2 at the time of study entry
• Planned treatment with (intravenous) immune modulating agents for any type of
cancer according to standard of care.
Exclusion criteria
• Unable to draw blood for study purposes (e.g. severe anemia Hb <5,5 mmol/L)
• Unable to safely obtain tumor biopsies
• Known human immunodeficiency virus (HIV), chronic hepatitis B or C infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74235.078.20 |