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Clinical Trials in South Korea / NCT07173790
Enrolling by invitation Observational

Watch and Wait or Worry and Wait in Indolent Lymphoma

NCT07173790 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Observational
Started
2025-10-01
Last updated
2025-11-21

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)Marginal Zone Lymphoma(MZL)Follicular Lymphoma, Grade 1Follicular Lymphoma, Grade 2Waldenström Macroglobulinemia (WM)Lymphoplasmacytic Lymphoma

Investigational drug(s) / intervention(s)

Patient-Reported Outcomes Survey

Patient-Reported Outcomes Survey: Participants will complete validated questionnaires including EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules (QLQ-CLL17, QLQ-NHL). Responses will be used to assess quality of life and psychological distress during watchful waiting.

Study summary

Indolent lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, low-grade follicular lymphoma, and Waldenström macroglobulinemia, are slow-growing cancers often managed initially with a watchful waiting strategy. This approach avoids unnecessary side effects of early therapy but may negatively impact patients' quality of life (QoL) due to anxiety, uncertainty, and self-monitoring of symptoms. Previous research has suggested increased distress and greater QoL decline in patients under observation compared to those receiving treatment, despite similar or lower disease burden. Moreover, poor QoL has been shown to independently predict overall survival in non-Hodgkin lymphoma patients. However, there are limited data from Asian populations, where cultural factors, health insurance systems, and treatment access differ significantly. This study will evaluate the impact of watchful waiting on patient-reported QoL among Korean patients with indolent lymphoma, providing evidence specific to this population and healthcare setting.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults ≥19 years old. * Diagnosed with indolent lymphoma (CLL/SLL, MZL, FL, or WM/LPL) at Seoul National University Hospital according to WHO criteria. * Currently managed with watch-and-wait (no active systemic therapy). * Able to understand and independently complete the study questionnaires. * Provide voluntary informed consent. Exclusion Criteria: * Receiving active systemic anti-lymphoma therapy at the time of enrollment. * Cognitive impairment or other condition preventing independent completion of the questionnaire.

Primary outcome measure(s)

  • Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) — At enrollment during a routine outpatient visit for patients managed with watch-and-wait; single assessment completed once on the day of enrollment (expected 20-30 minutes).
    Patient-reported quality of life will be measured using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which includes global health status/QoL, functional scales, and symptom items. Scores will be transformed to a 0-100 scale according to the official EORTC scoring manual; higher functional and global health scores indicate better quality of life, whereas higher symptom scores indicate worse symptoms.

Trial sites (4)

FacilityCityRegionStatus
Samsung Medical Center Seoul Gangnam-gu
Korea UniversityKorea University Guro Hospital Seoul Guro-gu
Seoul National University Hospital Seoul Jongno-gu
The Catholic University of Korea Seoul Seocho-gu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07173790 on ClinicalTrials.gov ↗ ← All trials in South Korea