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Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05372302
Collaborator
(none)
100
Enrollment
1
Location
14.8
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize according to WHO 2016 criteria

  • Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile

  • Define specific molecular signatures

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)
    Actual Study Start Date :
    Jul 8, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. samples to confirm and standardize [15 month]

      Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize it according to WHO 2016 criteria

    Secondary Outcome Measures

    1. Tissue Bank [15 month]

      Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile

    2. specific molecular signatures [15 month]

      Define specific molecular signatures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18 years

    • Signature of consent (for patients enrolled in the prospective part of the study)

    • Histological diagnosis of renal cell carcinoma of the Bellini collecting duct RCC

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione IRCCS Istituto Nazionale Tumori Milano Italy 20133

    Sponsors and Collaborators

    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    Investigators

    • Principal Investigator: Filippo De Braud, Prof, Fondazione IRCCS Istituto Nazionale Tumori - Milano

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    ClinicalTrials.gov Identifier:
    NCT05372302
    Other Study ID Numbers:
    • INT 12/21
    First Posted:
    May 12, 2022
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Ductal
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of May 12, 2022