Feasibility of the analysis of platinum-DNA adducts in tumour tissue in cisplatin-treated patients with advanced gastric cancer

Feasibility of the analysis of platinum-DNA adducts in tumour tissue in cisplatin-treated patients with advanced gastric cancer - Platinum-DNA adduct analyisis in tumour tissue

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30393

Enrollment

Registered

2006-11-23

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer gastric malignancies

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Any psychological, familial, sociological or geographical condition that may interfere with compliance with the study protocol

Design outcomes

Primary

Measure	Time frame
-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	—

Measure

Time frame

-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

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results