The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression. (KP-CARAIBES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06046131
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Pointe-a-Pitre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Adenocarcinoma Neoplasm Recurrence Neoplasm Metastasis Other: Standard care Not Applicable

Detailed Description:
There is a lack of information to predict the course of prostate cancer following its initial diagnosis; in other words, why some are indolent and evolve very slowly and others are aggressive, evolve rapidly with an increased risk of metastasis development and death. In addition, these evolutions do not seem similar according to ethno-geographic origins. We therefore hypothesize that in addition to genetic susceptibility factors specific to individuals and / or linked to their ethno-geographic origins, medical, occupational and environmental factors can influence the course of the disease and the response to treatments. We will build two prospective cohorts of incident cases of prostate cancer, one in Guadeloupe (whose population is predominantly Afro-descendant) and one in Rennes (Brittany, whose population is mainly of Caucasian origin). Each patient will be subject to longitudinal follow-up over time. Structured questionnaires will be administered at the time of diagnosis and at regular times after the initial treatment or subsequent treatments. They will focus on socio-demographic data, places of residence, education levels, lifestyles (tobacco, alcohol), personal and family medical history, current treatments, current and past occupational activities. Anthropometric and blood pressure measurements will be made at the time of diagnosis and at regular times after treatment. Saliva, urine and blood samples will be obtained. Clinical data related to the disease will be collected continuously.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Any patient with a histologically confirmed incident case of prostate cancer will be included in the study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Actual Study Start Date : February 28, 2023
Estimated Primary Completion Date : February 28, 2039
Estimated Study Completion Date : February 28, 2039

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Patients prostate cancer
Patient with a confirmed diagnosis of prostate cancer will be included before starting any treatment. Recruitment will be carried out by urologists from the urology departments of the CHU of Guadeloupe and the CHU of Rennes.
 Other: Standard care

Extra blood collection for dosages Urine collection for the dosage of non-persistent pollutants, isolation of extracellular vesicles released in urine, analysis of the microbiome, metagenomics to obtain a complete description of the bacterial functions represented as well as other microorganisms present, metabolome profiling and identification and/or assays of any other biological compound of interest strictly related to the specific objectives of the research.

Saliva collection for the extraction of the constitutional DNA. An interview using a structured questionnaire A quality of live auto-questionnaire

Other Name: Extra blood collection, urine collection and saliva collection, questionnaire.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. association between determinants (independent variables) and health events linked to disease progression (dependent variables) [ Time Frame: At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment. ]

    dependent variables: These are mainly criteria relating to :Discharge from active surveillance, Biological recurrence,Radiological, loco-regional or distant progression,

    Independant variables. These are mainly criteria relating to :

    Date of initial treatment and dates of successive treatments, Gleason score (ISUP) at diagnosis Gleason score (ISUP) on surgical specimen pTNM stage after surgery Body mass index [kg/m²], percentage of fat mass, % of water mass, % of bone mass estimated by bio-impedance.

    Metabolic syndrome (3 of the following 5 criteria): triglycerides > 1.7 mmo



Secondary Outcome Measures :
  1. association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables). [ Time Frame: : At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment. ]
    Dependent variables Adverse events (disease-related or treatment-related) rated according to CTCAE grades (Common Terminology Criteria for Adverse Events) Micturition disorders estimated by the International Prostate Symptom Score (IPSS) Erectile function estimated by the IIEF5 score (International Index of Erectile Function) Quality of life estimated by the FACT-P score (Functional Assessment of Cancer Therapy-Prostate) Independent variables These are the same as those indicated for the primary endpoints.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria:

Adult patients with incident case of prostate cancer Patient consulting the University Hospital of Guadeloupe or the University Hospital of Rennes Patient who resides in the departments of Guadeloupe or Martinique or the community of Saint-Martin or in Britany Patient affiliated or beneficiary of the social security signed consent

Exclusion Criteria:

Physical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046131


Contacts
Layout table for location contacts
Contact: Valérie HAMONY-SOTER +590 590 93 46 77 valerie.soter@chu-guadeloupe.fr
Contact: Eunice NUBRET +590 590 93 46 86 eunice.nubret@chu-guadeloupe.fr

Locations
Layout table for location information
France
CHU of Rennes Not yet recruiting
Rennes, Ille-et-Vilaine, France, 35000
Contact: Valérie Hamony Soter    +590 590 93 46 77    valerie.soter@chu-guadeloupe.fr   
Contact: Romain MATHIEU    +33 (0)6 63 69 70 30    romain.mathieu@chu-rennes.fr   
Principal Investigator: Romain MATHIEU         
Guadeloupe
CHU of Guadeloupe Recruiting
Pointe-à-Pitre, Guadeloupe, 97159
Contact: Valérie Hamony Soter    +590 590 93 46 77    valerie.soter@chu-guadeloupe.fr   
Principal Investigator: Laurent BRUREAU         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre
Institut National de la Santé Et de la Recherche Médicale, France
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
ClinicalTrials.gov Identifier: NCT06046131    
Other Study ID Numbers: PAP_RIPH2_2020/26
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplasms
Neoplasm Metastasis
Recurrence
Disease Progression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes