Status:
TERMINATED
In Situ Clonal Heterogeneity in Prostatic Diagnostic Biopsies
Lead Sponsor:
Clinica Luganese Moncucco
Conditions:
Prostate Cancer
Genetic Predisposition
Eligibility:
MALE
Brief Summary
This is a retrospective, proof of concept study, which aims at reconstructing the cellular heterogeneity of the tumor in multi-needle diagnostic prostate biopsy as well as any biopsy containing potent...
Detailed Description
Prostate cancer (PCa) is the leading malignancy of the male population. In current clinical practice, diagnostic confirmation of PCa is based on image-guided multi-needle biopsy, in order to capture t...
Eligibility Criteria
Inclusion
- The inclusion criteria for the subjects in the indolent cohort will be:
- a local disease with Gleason ≤ 7 (3+4, i.e. more differentiated tissue is found in diagnostic biopsies, better overall prognosis)
- no metastasis whatsoever during the follow-up;
- The inclusion criteria in the early-metastatic aggressive cohort will be:
- an advanced prostatic neoplasia with Gleason score ≥ 7 (4+3, i.e. less differentiated tissue is found in diagnostic biopsies, worse overall prognosis)
- multiple synchronous or metachronous metastasis.
- Exclusion Criteria:
- insufficient material on the tissue biopsy to be left in archives for further evaluations/analyses;
- insufficient amount of tumor cells at baseline;
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04873427
Start Date
April 15 2021
End Date
January 15 2023
Last Update
February 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alessandra Franzetti Pellanda
Lugano, Canton Ticino, Switzerland, 6900