The purpose of this study is to determine the feasibility of a sensitive technique for the analysis of platinum-DNA adducts in tumour tissue. We will:-Assess the feasibility of the analysis of platinum-DNA adducts in tissue using inductively coupled…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Assessment of the feasibility of the analysis of platinum-DNA adducts in
tissue using inductively coupled plasma mass spectrometry and the determination
of the minimal amount of tissue needed for the assessment of platinum-DNA
adducts
-Determination of platinum-DNA adducts in vital gastric tumour tissue, necrotic
gastric tumour tissue and normal gastric tissue 24 hours after start of
chemotherapy
-Determination of platinum-DNA adducts in PBMCs at the start of the infusion,
1, 2, 3, 4, 4.5, 5, 6, 8 and 24 hours after start of the infusion
-Determination of platinum in plasma and plasma ultrafiltrate at the start of
the infusion, 1, 2, 3, 4, 4.5, 5, 6, 8 and 24 hours after start of the infusion
Secondary outcome
Not applicable.
Background summary
Cisplatin exerts its cytotoxic action by formation of platinum-DNA adducts.
Often, these adducts are quantitated in peripheral white blood cells as
surrogate for levels in tumour tissue. Some studies, however, have shown that
good correlations between levels in peripheral blood mononuclear cells (PBMCs)
and tumour tissue are lacking. Therefore, it is of interest to explore
platinum-DNA adduct levels in tumour tissue. For this aim we developed a
sensitive technique to determine platinum-DNA adducts in tumour cells implying
only a small amount of tumour tissue.
Study objective
The purpose of this study is to determine the feasibility of a sensitive
technique for the analysis of platinum-DNA adducts in tumour tissue. We will:
-Assess the feasibility of the analysis of platinum-DNA adducts in tissue
using inductively coupled plasma mass spectrometry and determine the minimal
amount of tissue needed for isolation of DNA and the analysis of platinum-DNA
adducts.
-Determine whether there is a relationship between the amount of platinum-DNA
adducts in normal gastric tissue, vital gastric tumour tissue, necrotic gastric
tumour tissue and PBMCs.
Study design
This is a prospective study in which patients who receive cisplatin for gastric
cancer will be included. Patients will be asked to donate blood samples at
predefined time points during and after the first cisplatin chemotherapy
infusion. Cisplatin will be administered in a 4-hour during infusion. A
gastroscopy, including biopsy will be performed 24 hours after start of the
chemotherapy infusion.
Study burden and risks
Blood samples will be taken during and after cisplatin infusion. Therefore
patients will be exposed to extra blood sampling. Furthermore, approximately
150 mg tissue of normal gastric tissue, vital tumour tissue and necrotic tumour
tissue will be collected during a gastroscopy 24 hours after the start of
cisplatin infusion. The inconvenience of this gastroscopy is minimised by
throat anaesthesia and sedation. Biopsies taken during gastroscopy can lead to
small bleedings. These bleedings, however, generally stop immediately.Patients
will not experience benefit of participation in this study. However, data
acquired from this study will be used to assess the value of the determination
of platinum-DNA adducts in tumour tissue. These data will be used to optimise
the method for the determination of platinum-DNA adducts in tissue.
Plesmanlaan 121
2012 WN
Nederland
Plesmanlaan 121
2012 WN
Nederland
Listed location countries
Age
Inclusion criteria
-Patients treated with cisplatin for gastric cancer in The Netherlands Cancer Institute
-Patients who receive the first cisplatin chemotherapy infusion
-Age >= 18 years
-Performance: WHO 0-2
-Life expectancy > 3 months
-Written informed consent prior to participation
-Able and willing to undergo blood sampling for platinum analysis
-Able and willing to undergo tissue biopsy during gastroscopy. The eligibility of patients to undergo gastroscopy and biopsy is left to the discretion of the responsible oncologist
Exclusion criteria
Any psychological, familial, sociological or geographical condition that may interfere with compliance with the study protocol
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 | NL14956.031.06 |