Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03630536 |
| Other study ID # |
TRRI-REGISTRY |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2018 |
| Est. completion date |
May 8, 2028 |
Study information
| Verified date |
January 2024 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
Site Public Contact |
| Phone |
(844) 722-8774 |
| Email |
TRRI[@]cchmc.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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.
