NCT06207487

Brief Summary

Herpes zoster (HZ) is an important infectious complication among patients with cancer, particularly in the setting of treatment-related immunosuppression. This retrospective observational cohort study aimed to characterize the clinical profile of HZ episodes and estimate direct hospital costs associated with emergency department visits and hospitalizations in patients with active malignancy treated at a Brazilian tertiary cancer center. The study also explored associations between cancer characteristics, recent oncologic therapies, and clinical outcomes, including postherpetic neuralgia, recurrence, disease dissemination, and hospital costs. Findings are intended to support future budget impact and cost-effectiveness analyses of herpes zoster vaccination in oncology populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5.3 years

First QC Date

January 5, 2024

Last Update Submit

July 30, 2026

Conditions

Keywords

herpes zostercancercostspostherpetic neuralgia

Outcome Measures

Primary Outcomes (2)

  • Clinical characteristics of herpes zoster episodes

    Characterization of herpes zoster episodes in adult patients with active cancer, including clinical presentation, dissemination, postherpetic neuralgia, recurrence, cancer type and stage, and recent oncologic therapies.

    September 2019 through December 2024

  • Direct hospital costs

    Estimation of direct hospital costs associated with emergency department visits and hospitalizations related to herpes zoster in patients with active cancer.

    September 2019 through December 2024

Secondary Outcomes (1)

  • Postherpetic neuralgia

    3 months after herpes zoster episode

Study Arms (1)

Patients with Herpes Zoster and Active Cancer

Adult patients with active solid or hematologic malignancies who presented with a clinically confirmed episode of herpes zoster between September 2019 and December 2024 at A.C. Camargo Cancer Center, São Paulo, Brazil.

Other: Herpes Zoster episode

Interventions

Clinically confirmed herpes zoster episode (initial episode or recurrence) identified through electronic medical records.

Patients with Herpes Zoster and Active Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (≥18 years) with active solid or hematologic malignancies evaluated at A.C. Camargo Cancer Center (São Paulo, Brazil) who experienced a clinically confirmed episode of herpes zoster during the study period.

You may qualify if:

  • Clinically confirmed episode of herpes zoster (initial episode or recurrence). Herpes zoster diagnosed based on a typical painful dermatomal rash with polymorphic lesions (macules, papules, vesicles, and crusts), either localized or disseminated.

You may not qualify if:

  • Patients in whom herpes zoster was not confirmed after medical record review.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.C.Camargo Cancer Center

São Paulo, São Paulo, 01509-001, Brazil

Location

MeSH Terms

Conditions

Herpes ZosterNeoplasmsNeuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

September 1, 2019

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations