Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression. (KP-CARAIBES)
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ClinicalTrials.gov Identifier: NCT06046131 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostatic Neoplasm Adenocarcinoma Neoplasm Recurrence Neoplasm Metastasis | Other: Standard care | Not Applicable |
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 |
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.
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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. |
- 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
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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).
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
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 |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |