NCT06207487

Brief Summary

Rationale. Cancer patients are more likely to develop herpes zoster (HZ) and its complications. An acute episode of HZ implies in postponement of current cancer treatments, hospitalization, high risk of development of postherpetic neuralgia and high costs for paying sources. A better understanding of disease incidence, hospitalization, development of postherpetic neuralgia, and costs generated for funding sources may increase awareness of the impact of vaccination on oncology population. Objectives. Obtain HZ incidence and percentage of hospitalization in study population according to cancer type, topography, and stage. Estimate hospital costs arising from hospitalizations for different paying sources: National Public Health System (SUS - Unified Health System), health operators and private source (patient). Methods. We propose a retrospective descriptive study of HZ episodes occurred in oncological population attended at AC Camargo Cancer Center between 2019 September and 2022 August.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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
29 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

14 days

First QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Keywords

herpes zostercancercostspostherpetic neuralgia

Outcome Measures

Primary Outcomes (1)

  • Occurence

    Profile the occurrence of HZ in oncological population treated in a Brazilian cancer center.

    Between 2019 september at 2 years.

Eligibility Criteria

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

Adult cancer population (solid tumor or hematologic malignancies) from Ac Camargo Cancer Center, São Paulo - Brazil.

You may qualify if:

  • Admission at AC Camargo Cancer Center between 2019 september and 2022 august at emergency department and/or inpatient ward, including intensive care unit
  • Acute episode of Herpes Zoster or recurrence (see item 5.1. for ICD-10 codes).
  • Acute episode of HZ is clinically defined as painful, polymorphic, acute cutaneous lesions composed of macules, papules, vesicles and crusts at different stages of development, affecting delimited dermatomes or disseminated (when it affects two or more dermatomes).
  • Recurrence of HZ is defined as any occurrence of HZ that happens after the initial episode.
  • Active cancer is defined as: diagnosis of local, regionally advanced or metastatic cancer; treatment naïve, receiving oncological therapies or palliative care in the last year.

You may not qualify if:

  • Age under 18 years
  • Absence of evidence of oncological disease: cases classified as complete remission or without evidence of oncological disease (not receiving any kind of oncological treatment for at least one year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

Anna P Romero de Oliveira, physician

CONTACT

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

February 15, 2024

Primary Completion

February 29, 2024

Study Completion

December 30, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share