Clinical trial NCT04919122: Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Official title: Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Renal Cell Carcinoma
Keywords: ODYSSEY
mRCC
Metastatic Renal Cell Carcinoma
RCC
PRO
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Bristol-Myers Squibb
name: Exelixis
name: Merck Sharp & Dohme LLC
name: Pfizer
First posted: 2021-06-09
Enrollment: 800
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic renal cell cancer (mRCC) will be identified and undergo consent and baseline assessments, including research blood collection and processing. Patient reported outcomes will be collected at baseline (pre-treatment) every 3 months for 2 years, and then every 6 months until end of follow up (with a minimum follow-up of 18 months and a maximum follow-up period of 36 months; additional follow up will be obtained based on continuous funding).

Brief summary: 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.

Detailed description: This trial 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. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physician selection of particular agents, and discontinuation of therapies.

The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.

Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study.

Subsequent follow up with be coordinated centrally by DCRI. Additional clinic data will be obtained via PCORnet data pull and Medicare claims. Patient reported outcomes, quality of life and medications data will be obtained via the DCRI Call Center through follow-up phone interviews.

Eligibility criteria: Inclusion Criteria:

* Age 19 or over at time of informed consent.
* 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.

  1. Prior surgery and radiation therapy are permitted.
  2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
  3. Patients currently not on therapy and being observed are permitted.
* Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* Ability to comply with completion of PROs

Exclusion Criteria:

* 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.
* Patients who are not intending to undergo follow up care at a study site within PCORnet

Primary outcomes:
measure: Change in medication adherence as measured by patient report.
timeFrame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
measure: Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19
timeFrame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
measure: Change in symptom burden in mRCC patients receiving therapy as measured by FKSI-19
timeFrame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
measure: Change in quality of life in mRCC patients receiving therapy as measured by FACT-G
timeFrame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
measure: Change in symptom burden in mRCC patients receiving therapy as measured by FACT-G
timeFrame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Secondary outcomes:
measure: First line management choice(s)
timeFrame: Up to 36 months
measure: Subsequent line management choice(s)
timeFrame: Up to 36 months
measure: Dosing (starting dose, dose intensity, ending dose)
timeFrame: Up to 36 months
measure: Dose holds and dose interruptions
timeFrame: Up to 36 months
measure: Time on treatment
timeFrame: Up to 36 months
measure: Time to next treatment
timeFrame: Up to 36 months
measure: Early discontinuation of one agent of a combination
timeFrame: Up to 36 months
measure: Concomitant glucocorticoid use
timeFrame: Up to 36 months
measure: Work Productivity and Activity Impairment (WAPI) questionnaire
timeFrame: Up to 36 months
measure: Health care resource utilization (including hospitalizations)
timeFrame: Up to 36 months
measure: Overall survival (OS) of mRCC patients
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: State University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: The Regents of the University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
Study officials:
affiliation: Duke University
name: Daniel George, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhavsar NA, Harrison MR, Scales CD, Zhang T, Troy J, Ward K, Jabusch SM, Lampron Z, George DJ. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024 Jul 3;66:75-81. doi: 10.1016/j.euros.2024.06.007. eCollection 2024 Aug.