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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630536
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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
Renal Cell Carcinoma

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

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative
Actual Study Start Date : August 12, 2018
Estimated Primary Completion Date : May 2028
Estimated Study Completion Date : May 8, 2028





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Any age population with a diagnosis of a TFE Renal Cell Carcinoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630536


Contacts
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Contact: Site Public Contact (844) 722-8774 TRRI@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact    844-722-8774 ext 8447228774    TRRI@cchmc.org   
Principal Investigator: James Geller, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: James Geller, MD Children's Hospital Medical Center, Cincinnati
Additional Information:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03630536    
Other Study ID Numbers: TRRI-REGISTRY
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases