TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative
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|ClinicalTrials.gov Identifier: NCT03630536|
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : June 4, 2020
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:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
|Condition or disease|
|Renal Cell Carcinoma|
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.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
- 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.
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
|Contact: Site Public Contact||(844) 722-8774||TRRI@cchmc.org|
|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|
|Principal Investigator:||James Geller, MD||Children's Hospital Medical Center, Cincinnati|