In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.
While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.
The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.
the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.
The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.
Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasm | Procedure: prostate biopsy Other: Urinary sampling Other: Rectal swabbing before biopsies are performed | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 260 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Urinary and Prostate Microbiotes and Prostate Cancer |
Actual Study Start Date : | February 15, 2021 |
Estimated Primary Completion Date : | October 15, 2022 |
Estimated Study Completion Date : | October 15, 2023 |
Arm | Intervention/treatment |
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Experimental: cancer group |
Procedure: prostate biopsy
All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.
Other: Urinary sampling It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative
Other: Rectal swabbing before biopsies are performed A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling
|
Experimental: control group |
Procedure: prostate biopsy
All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.
Other: Urinary sampling It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative
Other: Rectal swabbing before biopsies are performed A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: romain LOTTE | 33492036218 | lotte.r@chu-nice.fr |
France | |
Cannes hospital | Recruiting |
Cannes, France, 06400 | |
Contact: romain Lotte 0492036218 lotte.r@chu-nice.fr | |
Contact: Aysha Shaikh shaikh.a@chu-nice.fr | |
Principal Investigator: romain haider | |
Principal Investigator: yohan bodokh | |
Principal Investigator: patrick-julien treacy | |
marseille Hospital | Recruiting |
Marseille, France, 13000 | |
Contact: eric Lechevallier 0491435188 elechevallier@ap-hm.fr | |
Principal Investigator: erci Lechevallier | |
nice Hospital | Recruiting |
Nice, France, 06000 | |
Contact: romain LOTTE 33492036218 lotte.r@chu-nice.fr | |
Principal Investigator: durand Matthieu | |
Tours hospital | Recruiting |
Tours, France, 37000 | |
Contact: Franck Bruyere 02 34 38 95 42 F.BRUYERE@chu-tours.fr | |
Principal Investigator: franck Bruyere |
Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2019 | ||||
First Posted Date ICMJE | May 13, 2019 | ||||
Last Update Posted Date | May 3, 2021 | ||||
Actual Study Start Date ICMJE | February 15, 2021 | ||||
Estimated Primary Completion Date | October 15, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of 6 bacterial species in prostate biopsy [ Time Frame: 48 months ] detection in prostate biopsy by real-time PCR and/or culture followed by identification by MALDI-TOF mass spectrometry of at least one of the following 6 bacterial species : S. anginosus, V. cambriense, P. lymphophilum, A. lactolyticus, A. obesiensis and A. schaalii.
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Original Primary Outcome Measures ICMJE |
detection in prostate biopsy of at least one of the following 6 bacterial species [ Time Frame: 48 months ] detection in prostate biopsy by real-time PCR and/or culture followed by identification by MALDI-TOF mass spectrometry of at least one of the following 6 bacterial species : S. anginosus, V. cambriense, P. lymphophilum, A. lactolyticus, A. obesiensis and A. schaalii.
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Urinary and Prostate Microbiotes and Prostate Cancer | ||||
Official Title ICMJE | Urinary and Prostate Microbiotes and Prostate Cancer | ||||
Brief Summary |
In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted. While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers. The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition. the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2. The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Prostatic Neoplasm | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
260 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 15, 2023 | ||||
Estimated Primary Completion Date | October 15, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03947515 | ||||
Other Study ID Numbers ICMJE | 18-API-02 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Centre Hospitalier Universitaire de Nice | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |