Clinical trial NCT05372302: Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)
Official title: Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Collecting Duct Carcinoma
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with certain / suspected diagnosis of carcinoma of the collecting ducts

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


Eligibility criteria: 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:

-

Primary outcomes:
measure: samples to confirm and standardize
timeFrame: 15 month
Secondary outcomes:
measure: Tissue Bank
timeFrame: 15 month
measure: specific molecular signatures
timeFrame: 15 month
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale Tumori - Milano
name: Filippo De Braud, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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