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临床试验/NCT05558735
NCT05558735已完成不适用

Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2022年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
2
主要终点
"The primary outcomes measures are the sensitivity (Se) and specificity (Sp) of canine detection for the diagnosis of prostate cancer and the Kappa concordance coefficient. "

研究概览

简要总结

The sense of smell allows both humans and dogs to carry out a chemo-sensory analysis of their environment. Volatile organic compounds enter the nasal cavities and bind to receptors in the nasal mucosa. Neuroepithelium cells perform chemoelectric transduction of olfactory information. The latter is supported by one of the fibers of the olfactory nerve which crosses the cribriform plate of the ethmoid to arrive in the olfactory bulb of the brain. Incorporating this information can lead to behavioral responses. The dog has a sense of smell 100,000 times more sensitive than humans, it is able to detect one particle among 1 trillion. The use of detection dogs involves learning the behavioral response to an olfactory stimulus. Prostate cancer represents 25% of male cancers, it is the second deadliest cancer in France with 10,000 deaths per year. Diagnosis of prostate cancer requires a Prostate Specific Antigen (PSA) blood test and a digital rectal examination. In the event of an abnormality in one of these parameters, a prostate MRI is indicated, supplemented by prostate biopsies in the event of an abnormal MRI. However, one situation remains open to discussion: what should be done when faced with a normal MRI despite an abnormal PSA level or digital rectal examination? In this situation and according to current recommendations, the practitioner has the choice between performing prostate biopsies, i.e. an invasive procedure with a high risk of being negative, and simple monitoring, this time with the risk of missing the diagnosis of prostate cancer. Several studies have shown the effectiveness of dogs in detecting very specific volatile organic compounds. Can the investigators train them to detect the catabolites of prostate tumours?

详细描述

"The purpose of this study is to validate the diagnostic aid performance of canine detection of high-risk prostate cancers (Gleason score 7 or more) by comparing it to prostate MRI with respect to the results of biopsies of the prostate, then to integrate this test into the current diagnostic strategy for prostate cancer.

We will carry out a descriptive observational prospective case-control study at the Bichat-Claude Bernard and Henri Mondor hospitals (France) in routine care in adult patients suspected of prostate cancer and having an indication for the realization of a urine sample, an MRI prostate cancer and prostate biopsies.

The patient journey will be as follows :

During the initial visit (V1), patients suspected of prostate cancer (pathological digital rectal examination, PSA > 4) are informed about the study. They can entrust their non-objection to participate in the study now, or return during a new visit (V2) after a reflection period of 2 to 6 weeks.

Each patient completed a clinical information questionnaire. A 60 ml urine sample is taken, part of which is used to perform the ECBU necessary for performing prostate biopsies. The remainder of the sample is used for research.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • "Inclusion criteria :
  • Older than 18 years old
  • Requiring the realization of a collection of urine from the framework of their care
  • Requiring a PSA blood test, prostate MRI and prostate biopsies in the framework of their care

排除标准

  • Absence of signed informed consent
  • People who do not speak French
  • Persons whose general condition does not allow to participate in the study
  • Protected populations: under guardianship or under curatorship
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons receiving care psychiatric
  • Absence of affiliation to a pension scheme social Security"

研究组 & 干预措施

case group

The case group is composed of Adult male with a positive biopsy (Gleason score greater than or equal to 7)

干预措施: urine collection (Other)

case group

The case group is composed of Adult male with a positive biopsy (Gleason score greater than or equal to 7)

干预措施: canine detection (Other)

control group

The control group is made up of adult men performing a biopsy whose Gleason score is less than or equal to 6.

干预措施: urine collection (Other)

control group

The control group is made up of adult men performing a biopsy whose Gleason score is less than or equal to 6.

干预措施: canine detection (Other)

结局指标

主要结局

"The primary outcomes measures are the sensitivity (Se) and specificity (Sp) of canine detection for the diagnosis of prostate cancer and the Kappa concordance coefficient. "

时间窗: 24 months

The Se, the Sp and the kappa coefficient will be calculated for each diagnostic method (MRI and canine detection). The definitive diagnosis will be given by the results of the prostate biopsies.

次要结局

  • Show that the percentage of marking of the dog when the MRI is negative and the biopsy positive is significantly greater than 50% (correct marking by simple chance).(24 months)
  • Calculate the Kappa coefficient quantifying the concordance between canine detection and biopsy, first among patients with negative MRI then among patients with positive MRI.(24 months)
  • Compare the diagnostic score obtained using all the examinations carried out when prostate cancer is suspected (assay of the PSA level, digital rectal examination, MRI, prostate biopsy) with the score obtained by adding canine detection.(24 months)
  • Perform a mass spectrometry examination on samples from the "case" group(24 months)
  • "Compare the canine detection performances of prostate cancer (Se and Sp) according to different parameters of the patient's lifestyle, according to the different grades of cancer, and according to breeds and ages of dogs."(24 months)
  • "Compare the performance of canine detection of prostate cancer (Se and Sp) with detection performance of prostate cancer by measuring the blood PSA level."(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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