Biomarkers of Renal Cancer

NCT05785052 | Recruiting

• 1 other identifier: BRC
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 4

Brief Summary

The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe). This new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.

Conditions

Renal Cell Carcinoma; Tumor, Solid; Oncocytoma; Angiomyolipoma

Keywords

Biomarkers; Urology; Renal Cell Carcinoma; Molecular Biomarkers; Oncology

Outcome Measures

Primary Outcomes (3)

• Screening

  Identification of biomarkers able to predict the presence of a renal mass, defined as a mass either benign or malignant recorded at axial imaging examination (either CT or MRI).

  Analysis of biological samples collected before surgery

• Diagnosis

  Identification of biomarkers able to predict the presence of a Renal Cell Carcinoma, defined as a renal malignancy

  Analysis of biological samples collected before surgery

• Prognosis

  Identification of biomarkers able to predict the presence of an aggressive Renal Cell Carcinoma

  Analysis of biological samples collected before surgery

Study Arms (2)

Renal-mass patients

Patients diagnosed with a first episode of renal mass attending the urology department.

Control subjects

Patients affected by urological functional diseases or living kidney donor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases: patients diagnosed with a first episode of renal mass. Control subjects: living kidney donor or patient with urological functional diseases.

You may qualify if:

• Men and women over 18 years of age
• Diagnosis of first episode of renal mass
• Caucasian race
• Signed, informed consent

You may not qualify if:

• Any other concomitant cancer or history of active cancer in the last 5 years
• Oncological genetic syndrome
• Previous history of renal tumour
• Urothelial cancer
• End-stage renal disease on hemodialysis
• Bilateral renal cell carcinoma
• Men and women over 18 years of age
• Caucasian race
• Living kidney donor or patient with urological functional diseases (e.g. kidney stones, benign prostate hypertrophy, etc..)
• Signed, informed consent
• History of active cancer in the last 5 years
• Oncological genetic syndrome
• End-stage renal disease on hemodialysis or peritoneal dialysis

Sponsors & Collaborators

• Biorek S.R.L.: lead

Study Sites (4)

Azienda Ospedaliera Universitaria Careggi

Florence, 50139, Italy

RECRUITING

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Fundació Puigvert

Barcelona, 08025, Spain

RECRUITING

Related Publications (25)

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  PMID: 25684695 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The samples will be fractionated and subjected to different analysis, such as the detection of nucleic acids (DNA and RNA), and proteins. These macromolecules will be purified and analyzed by employing methods such as real time PCR, microarrays, sequencing, ELISA assays, or mass spectrometry.

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms; Adenoma, Oxyphilic; Angiomyolipoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenoma; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Perivascular Epithelioid Cell Neoplasms

Study Officials

• Francesco Montorsi

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Trevisani

CONTACT

0226435857; francesco.trevisani@biorek.eu

Alessandra Cinque

CONTACT

0226435857; alessandra.cinque@biorek.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: June 11, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

ES (1); IT (3)