NCT03630536

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. 1.Existing clinical and/or cancer registry databases
  2. 2.Referrals from clinicians, surgeons, or pathologists
  3. 3.Families initiating contact with Registry staff directly

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2018Jun 2026

First Submitted

Initial submission to the registry

June 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

7.8 years

First QC Date

June 22, 2018

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improving Future Research

    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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Katherine Somers, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

August 15, 2018

Study Start

August 12, 2018

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations