ACTIVE_NOT_RECRUITING

Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings.

Official Title

Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

Quick Facts

Study Start:2022-04-01
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04919122

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.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 19 or over at time of informed consent.
  2. * Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-line systemic therapy for mRCC.
  3. 1. Prior surgery and radiation therapy are permitted.
  4. 2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
  5. 3. Patients currently not on therapy and being observed are permitted.
  6. * Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  7. * Ability to comply with completion of PROs
  1. * Patients being treated for metastatic solid tumors other than mRCC are excluded. Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers are permitted.
  2. * Patients who are not intending to undergo follow up care at a study site within PCORnet

Contacts and Locations

Principal Investigator

Daniel George, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

State University of Iowa
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Ochsner Clinic Foundation d/b/a Ochsner Health
New Orleans, Louisiana, 70121
United States
The Johns Hopkins University
Baltimore, Maryland, 21205
United States
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27710
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Geisinger Clinic
Danville, Pennsylvania, 17822
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Utah
Salt Lake City, Utah, 84112
United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Duke University

  • Daniel George, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Registration Dates

Study Start Date2022-04-01
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • ODYSSEY
  • mRCC
  • Metastatic Renal Cell Carcinoma
  • RCC
  • PRO

Additional Relevant MeSH Terms

  • Metastatic Renal Cell Carcinoma