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

January 16, 2024 updated by: Children's Hospital Medical Center, Cincinnati

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

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

  • Name: Site Public Contact
  • Phone Number: (844) 722-8774
  • Email: TRRI@cchmc.org

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 8447228774 844-722-8774
          • Email: TRRI@cchmc.org
        • Principal Investigator:
          • James Geller, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Any age population with a diagnosis of a TFE Renal Cell Carcinoma

Description

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

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

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving Future Research
Time Frame: 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.
From enrollment until data analysis is complete - assessed up to 40 years

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

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

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)

August 12, 2018

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 8, 2028

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRRI-REGISTRY

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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