Telomere Associated Variables (TAVs) in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04124900|
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 30, 2019
This research project results from the interest in continuing the collaboration with the previous LL-HURS-ONC001 clinical validation study, which gives cause to the present study. LL-HURS-ONC001 was carried out with the participation of HURS' Principal Investigator and the team of experts in prostate cancer, as well as with the participation of the Sponsor's scientific and development team, Life Length SL, led by Dr. Najarro.
The main objective of this study is to demonstrate the efficacy of the PROSTAV test in cutting down on unnecessary biopsies in prostate cancer screening/early diagnosis. PROSTAV is a minimally invasive test, easy to implement as biomarker for prostate cancer diagnosis. The efficacy of the PROSTAV test is clinically validated by the results obtained in a previous study, LL-HURS-ONC001.
The purpose of this study is to advance in the development of new biomarkers in areas where there is a clinical need and where the telomeric profile influences medical decisions within the patient's clinical context. The association level between each individual's telomere biology and the results of the prostate biopsy will be confirmed. Data will be collected to subsequently delve deeper into and accurately establish the effect of this measure in prostate cancer patient management to substantiate its implementation in standard care.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||535 participants|
|Official Title:||Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||November 15, 2020|
|Estimated Study Completion Date :||November 15, 2020|
patients at prostate cancer risk diagnosed
The study is composed of one single subject cohort. After risk evaluation, prostate biopsies will be performed for diagnostic purposes on all recruited patients. The cases are sorted into two groups after diagnosis:
- Telomere Associated Variables [ Time Frame: One day single measurement ]This is a clinical multicenter study focused on evaluating the efficacy of the PROSTAV test in patients at risk of prostate cancer based on data of telomere associated variables (TAV) as risk-score. The study comprises one single prospective observational phase.
Biospecimen Retention: Samples With DNA
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): NCT04124900
|Contact: Pilar Najarro||+(34) firstname.lastname@example.org|
|United States, Texas|
|Houston Methodist Research Institute||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vivian MacDonnell, CCRP 713-441-8113 email@example.com|
|Principal Investigator: Brian J Miles, MD|
|University Hospital Reina Sofía||Recruiting|
|Córdoba, Spain, 14004|
|Contact: María José Requena, MD (+34) 957 011 057|
|Contact: Enrique Gómez, MD (+34) 957 011 057|
|Principal Investigator: María José Requena, MD|
|Principal Investigator: Enrique Gómez, MD|
|Principal Investigator:||Maria José Requena||University Hospital Reina Sofía|