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A prospective study for the development of a quality of life questionnaire in renal cell carcinoma patients.

Development of an EORTC patient-reported outcome measure (questionnaire module) for renal cell cancer patients (provisional RCC-38): Phase III - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084174
Enrollment
495
Registered
2025-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C642- Malignant neoplasm of left kidney,except renal pelvis Health Condition 2: C652- Malignant neoplasm of left renal pelvis Health Condition 3: C641- Malignant neoplasm of right kidney, except renal pelvis Health Condition 4: C651- Malignant neoplasm of right renalpelvis Health Condition 5: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis Health Condition 6: C659- Malignant neoplasm of unspecifiedrenal pelvis

Interventions

Intervention1: Nil: The proposed study is an observational study. So no interventional drug or treatment is being given

Sponsors

Medical University of Innsbruck
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The overall inclusion criteria are the following: 1. Diagnosis of renal cell cancer (irrespective of treatment or follow up status) 2. 18 years of age or above 3. Indication of biological sex as male or female 4. No concurrent malignancies (should there be problems recruiting patients, this criterion could be made less strict and other cancers would be authorised, as long as they are in remission/not being treated) 5. No cognitive impairment 6. Fluency in the resident language of the collaborator (to complete the questionnaires and participate in the interview) 7. Written informed consent Further inclusion criteria are applied depending on the recruitment matrix cell for which a patient is to be assessed: 1. Disease stage 2. Current treatment 3. Sex-ratio of 2:1 (male:female)

Exclusion criteria

Exclusion criteria: The subtypes for RCC are not taken into account, as this would lead to a disproportionately large number of additional cells in the recruitment matrix.

Design outcomes

Primary

MeasureTime frame
The Phase III will result in a pre-tested version of the EORTC QLQ-RCC38 and a tentative scoring system. An interim report on the results on Phase IIIa and their implications on the module and Phase IIIb will be produced. A publication on the development process (summary of Phases I-II and IIIa/b) will serve as the final project report. At the end of Phase IIIb, the EORTC QLQ-RCC38 will be ready for international validation.Timepoint: On the day of enrollment in the study, patients will be required to complete a questionnaire. The overall duration of Phase III is estimated to be 36 months from the start of the project.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

Austria, Denmark, France, Germany, Greece, India, Israel, Jordan, Norway, Spain, United Kingdom

Contacts

Public ContactDr Manjunath Nookala Krishnamurthy

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

nk.manjunath@gmail.com9920703438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026