TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative

Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

There are limited data regarding the biology and treatment of TFE Renal Cell Carcinoma (TFE RCC). This project provides the infrastructure for acquisition of biological specimens, imaging, and correlative clinical data to facilitate biology studies and characterization of TFE RCC. This registry will collect clinical, demographic, and pathological data, specimens (as available) and imaging from patients with TFE RCC, prospectively. Cases are identified through:

  1. Existing clinical and/or cancer registry databases

  2. Referrals from clinicians, surgeons, or pathologists

  3. Families initiating contact with Registry staff directly

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The following data/materials will be collected for this registry study:

    Clinical Data: Demographic data, date of diagnosis, pathology, radiological imaging at diagnosis and relapse, signs and symptoms at diagnosis, molecular and biological data, staging details including sites of disease, detailed treatment data (e.g. types and dates of surgeries/interventional therapy (if any), medical/systemic therapy, radiotherapy), response to treatment, dates of progression, types of progression (local or metastatic), and follow-up data. The demographic and clinical data collected are abstracted and entered into an electronic data system secured by password protection (see section 4.3.3). Collection of existing molecular and/or genomic data or analysis that has been performed will also be included.

    Research Specimens:

    Tissue (fresh/frozen/FFPE) will be requested for all enrolled patients and sent for central review to study pathologist. Then tissue will be stored at CCHMC and future research testing may be conducted on this tissue.

    Optional research specimens:

    Pending consent specification of family/patient, and resources, specimens may be sent directly to collaborating laboratories to proceed with tumor modeling and drug testing, or other translational research with PI or designee via an IRB approved project.

    • Tumor Modeling (Fresh, frozen,): Prospectively collect or retain left-over tumor tissue samples and normal tissue (background kidney) as available, for research purposes.

    • Blood: prospectively collected at time of enrollment and at time of relapse

    • Urine: prospectively collected at time of enrollment and at time of relapse

    • Saliva: prospectively collected at time of or at one time point after at time of enrollment and at time of relapse

    Registry clinical data will be correlated with biological/bioinformatic and genomic data. Data stored in the Registry may be used to provide statistical data for scientific presentations and for preparation of peer-reviewed manuscripts. For such purposes all data will be de-identified. Beyond tumor model development and new agent drug testing (if selected in the consent process), data and specimens will be released for IRB approved research proposals upon approval from the TFE RCC Steering Committee.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Time Perspective:
    Official Title:
    TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative
    Actual Study Start Date :
    Aug 12, 2018
    Anticipated Primary Completion Date :
    May 1, 2028
    Anticipated Study Completion Date :
    May 8, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Improving Future Research [From enrollment until data analysis is complete - assessed up to 40 years]

      Improving future research by releasing tumor tissue for tumor modeling and drug testing, tumor biology insights, and clinical insights ultimately leading to the development of more effective therapies for children with TFE RCC.

    Eligibility Criteria


    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Inclusion Criteria:
    • All patients of any age with a suspected diagnosis or confirmed diagnosis of a TFE Renal Cell Carcinoma.

    • Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent.

    Exclusion Criteria:
    • Any patient that has not been diagnosed with TFE Renal Cell Carcinoma

    Contacts and Locations


    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati


    • Principal Investigator: James Geller, MD, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati Identifier:
    Other Study ID Numbers:
    First Posted:
    Aug 15, 2018
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2021