DNA Hypermethylation of a panel of 5 genes in urine samples as biomarker for bladder cancer diagnosis

DNA Hypermethylation of a panel of 5 genes as an urinary biomarker for bladder cancer diagnosis.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000258954

Enrollment

Registered

2020-02-27

Start date

2014-06-23

Completion date

2016-12-22

Last updated

2020-03-03

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

Conditions

None listed

Brief summary

The aim of this study is to measure the diagnostic accuracy (sensitivity and specificity) of a panel of five methylated gene promoters in urine samples for the detection of bladder cancer , whose sensitivity and specificity has been proven when studied in a separate fashion. Ideally, this would lead to the development of a DNA methylation-based diagnostic protocol in urine samples and optimisation of its sensitivity and specificity.

Interventions

The participants, patients and health individuals, provided a single urine sample (single cross-sectional assessment) before any routine diagnostic or therapeutic intervention. Only the patients underwent cystoscopy and transurethral resection of the bladder tumour.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patients group: Subjects with Bladder Cancer who are able to provide a urine sample and undergo a cystoscopy before any treatment. Control group: Subjects without any previous or current malignancy who are able to provide a urine sample.

Exclusion criteria

Individuals with metastasis to urinary bladder from other organs or other malignancies

Outcome results