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

May 9, 2022 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • 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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20133
        • Recruiting
        • Fondazione Irccs Istituto Nazionale Tumori
        • Contact:
          • Filippo De Braud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with certain / suspected diagnosis of carcinoma of the collecting ducts

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
samples to confirm and standardize
Time Frame: 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
15 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Bank
Time Frame: 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
15 month
specific molecular signatures
Time Frame: 15 month
Define specific molecular signatures
15 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 12/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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