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In Situ Clonal Heterogeneity in Prostatic Diagnostic Biopsies

NCT04873427 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-02-15

No results posted yet for this study

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 potentially pre-malignant tissue, to study its implications in the clinical history of the disease. For each patient, 2 or more samples will be prepared starting from the FFPE diagnostic material. The biopsy used for assigning the Gleason score will be sequenced, together with two or more of the local peri-proximal biopsies with a higher level of differentiation. Samples will undergo Whole Exome Sequencing with an average coverage of 300x at the Wellcome Sanger Institute (WSI, Hinxton, UK). Sequencing data will be analysed for single nucleotide variants, copy number variants and structural variants by using state-of-the-art data analysis pipeline at WSI.

1. Reconstruction of local PCa heterogeneity in multi-needle diagnostic biopsy with different Gleason scores (6-10) using high-coverage whole exome sequencing (WES) and DP-based clonal analysis;
2. Characterization of the relationships between pathological differentiation (Gleason score) and genomics-measured heterogeneity and malignancy features;
3. Assessment of clinical implications of clonal heterogeneity.

The study will include an average of 150 prostatic diagnostic biopsies from a cohort of 20 early metastatic PC patients and 20 non-relapsing/non-metastatic patients with indolent malignant disease.

Conditions

Interventions

GENETIC

clonal heterogeneity evaluation

Reconstruction of local PCa heterogeneity in multi-needle diagnostic biopsy with different Gleason scores (6-10) using high-coverage whole exome sequencing (WES) and DP-based clonal analysis

Sponsors & Collaborators

  • Clinica Luganese Moncucco

    lead OTHER

Principal Investigators

  • Alessandra Franzetti Pellanda, MD · Clinica Luganese Moncucco

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-01-15
Completion
2023-01-15

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04873427 on ClinicalTrials.gov