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Circulating tumor DNA in urothelial cancer.

Longitudinal kinetics of cancer mutations in the plasma, urine and tumor of patients with urothelial cancer treated with chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24518
Enrollment
80
Registered
2014-07-08
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Urothelial cancer -Blaaskanker

Interventions

- Peripheral blood samples - Urine samples - Tumor biopties

Sponsors

The Netherlands Cancer Institute- Antoni van Leeuwenhoek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Indication for systemic treatment with anti-cancer agents in patients with urothelial cancer. - WHO performance status 0-2 - age > 18yr - Written informed consent

Exclusion criteria

Exclusion criteria: - Coleection of tissue from a metastatic or primary lesion is not possible. - Pure non-urothelial carcinoma (SCC/Adenocarcinoma) of the bladder or urinary tract

Design outcomes

Primary

MeasureTime frame
To explore the longitudinal kinetics of tumor mutations in the urine and plasma of bladder cancer patients receicing systemic therapy fo locally advanced cancer or metastatic disease.

Secondary

MeasureTime frame
- To determine the detectability rate and range in levels ctDNA in plasma before start of treatment - To explore the correlation of levels of ctDNA in plasma with tumor burden - To explore the correlation between radiological response and urine ctDNA and plasma ctDNA kinetics during and following treatment - To explore the prognostic value of urine ctDNA and plasma ctDNA for treatment outcome (progression free survival) of neoadjuvant chemotherapy for bladder cancer - To explore the range and frequency of mutations found in ctDNA, urine ctDNA and tumor samples in bladder cancer. - Build a biobank of longitudinally collected bladder cancer samples for translational research.

Contacts

Public ContactM.S. Heijden, van der

Nederlands Kanker Instituut/Dutch Cancer Institute

ms.vd.heijden@nki.nl+31 20 512 6973

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)