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临床试验/NCT07080333
NCT07080333招募中不适用

BLADDER MICROBIOTA AND BLADDER CANCER

Centre Hospitalier Universitaire de Nice16 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2026年3月23日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
95
试验地点
16
主要终点
The biodiversity of the bacterial bladder microbiota by global metagenomics

研究概览

简要总结

In France, bladder cancer (BC) is the fourth leading cause of cancer (14,000 new cases per year). It affects older men (>60 years old) and smoking is the main identified risk factor (RF). The persistence of a high sex ratio despite the increase in smoking among women has led to research into other environmental RFs for BC, which may include the microbiota.

Recently, the concept of urinary microbiota in asymptomatic patients has been accepted. Studies on the urinary microbiota have shown dysbiosis associated with certain urogenital pathologies. Thus, similar to certain dysbiosis of the colonic mucosa microbiota associated with CRC, it is possible that certain bacteria or viruses in the bladder tissue microbiota may be involved in bladder carcinogenesis. An epidemiological study conducted by our laboratory showed a prevalence of BC of 14% (7/50) in patients carrying the bacterium Actinotignum schaalii in their urine. While studies have analysed the urinary microbiota of patients with BC, those comparing the microbiota of cancerous bladder tissue with that of healthy tissue in patients with BC remain few in number, involve a limited number of patients, use uncontrolled sample collection, and have all used 16S rDNA-targeted metagenomics methods to study the composition of the microbiota. The authors show a difference in biodiversity between the microbiota of cancerous bladder tissue and that of healthy tissue.

The team hopes to confirm these preliminary results with a multicentre study using a more comprehensive genomic method, global metagenomics. The microbiota of cancerous bladder tissue will be compared with that of healthy bladder tissue in the same patient to highlight any bacterial or viral dysbiosis associated with the cancerous area.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age > 18 years old
  • First RTUV for suspected CV in the presence of macroscopic haematuria or other clinical signs and/or urinary cytology and/or cystoscopy and/or imaging tests suggestive of CV
  • Signed informed consent form
  • Affiliation with a social security scheme

排除标准

  • Antibiotic use within 3 months prior to inclusion
  • Current urinary tract infection (urine culture recommended by the AFU prior to RTUV)
  • History of surgical treatment of the urinary and genital tracts within the last 6 months prior to inclusion
  • History of RTUV
  • History of pelvic radiotherapy
  • Interstitial cystitis
  • Patients with an indwelling urinary catheter
  • Vulnerable patients: minors, patients under guardianship or curatorship
  • Patients with benign tumours after receipt of the pathological report (inverted papilloma, non-tumour inflammatory lesion)

研究组 & 干预措施

patient with suspected bladder cancer

Experimental

干预措施: biopsy (Biological)

结局指标

主要结局

The biodiversity of the bacterial bladder microbiota by global metagenomics

时间窗: 36 months

description of biodiversity of bacterial bladder microbiota

次要结局

  • Global biodiversity of viral microbiota by metagenomics(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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