NCT06988865

Brief Summary

Oral clinical descriptions related to adverse events in patients treated with those elective multi-targeted receptor tyrosine kinase inhibitors and a recombinant humanised monoclonal antibody

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

May 1, 2025

Last Update Submit

May 22, 2025

Conditions

CancerGeographic Tongue

Keywords

antiangiogenic drugsglossitis benign migratory

Outcome Measures

Primary Outcomes (1)

  • Benign migratory glossitis

    erythematous erosions, with loss of filiform papillae, surrounded by white circinate rims on the dorsal tongue

    From enrollment to the end of study at 7 years

Secondary Outcomes (1)

  • Adverse events

    From enrollment to the end of study at 7 years

Study Arms (1)

angiogenesis inhibitors

Oral clinical manifestation

Other: Clinical evaluation

Interventions

Clinical evaluationOTHER

treatment methods, associated symptoms, evolution and clinical presentation

Also known as: clinical images
angiogenesis inhibitors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital -Instituto do Cancer do Estado de Sao Paulo-ICESP

You may qualify if:

  • patient's charts which underwent antiangiogenic targeted drugs

You may not qualify if:

  • chemoterapy without angiogenesis inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

NeoplasmsGlossitis, Benign Migratory

Condition Hierarchy (Ancestors)

GlossitisTongue DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Mauricio Neves Gomes, PhD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

  • Wagner Gomes da Silva, PhD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant, Dental Oncology Service, Instituto do Câncer do Estado de São Paulo (ICESP-FMUSP)

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 25, 2025

Study Start

July 16, 2017

Primary Completion

January 10, 2020

Study Completion

February 1, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

BR(1)