CancerNCT06988865
Benign Migratory Glossitis Associated With Antiangiogenic Drugs
An observational study of Cancer and Geographic Tongue, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Geographic Tongue
- What is being tested?
- Clinical evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jul 2017to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital -Instituto do Cancer do Estado de Sao Paulo-ICESP
Who may be able to join
- patient's charts which underwent antiangiogenic targeted drugs
Who cannot join
- chemoterapy without angiogenesis inhibitors
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: Benign Migratory Glossitis Associated With Antiangiogenic Drugs Used in Cancer Treatment
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
Read the detailed description
Electronical medical and dental records, high-resolution digital photograph were reviewed. Demographic data, medical background, clinical and laboratory information were recorded for each individual case.
- Conditions
- Cancer, Geographic Tongue
- Being tested
- Clinical evaluation
- Keywords
- antiangiogenic drugs, glossitis benign migratory
- Medical subject headings
- Neoplasms, Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
Also called clinical images
treatment methods, associated symptoms, evolution and clinical presentation
| Study group | Role | What they receive |
|---|---|---|
| angiogenesis inhibitors | Oral clinical manifestation Receives: Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benign migratory glossitis
erythematous erosions, with loss of filiform papillae, surrounded by white circinate rims on the dorsal tongue
Measured: From enrollment to the end of study at 7 years
Secondary outcomes (1)
Adverse events
Dysgeusia , dermatologic toxicities such as skin erythemas and vesicles on the palms of the hands and burning sensation
Measured: From enrollment to the end of study at 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start16 Jul 2017
- Primary completion10 Jan 2020
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAURICIO NEVES GOMES, Instituto do Cancer do Estado de São Paulo
- Investigators
- Mauricio Neves Gomes, PhD, Principal investigator, Instituto do Cancer do Estado de São PauloWagner Gomes da Silva, PhD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988865
- Sponsor's protocol ID
- Ethics Committee : 6.901.573
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Migratory Glossitis Associated With Antiangiogenic Drugs Used in Cancer Treatment
- ClinicalTrials.gov ID
- NCT06988865
- Acronym / sponsor ID
- Ethics Committee : 6.901.573
- Conditions
- Cancer, Geographic Tongue
- Keywords
- antiangiogenic drugs, glossitis benign migratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Electronical medical and dental records, high-resolution digital photograph were reviewed. Demographic data, medical background, clinical and laboratory information were recorded for each individual case.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| angiogenesis inhibitors | – | Other: Clinical evaluationOral clinical manifestation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital -Instituto do Cancer do Estado de Sao Paulo-ICESP
Key inclusion criteria (1 listed)
- patient's charts which underwent antiangiogenic targeted drugs
Key exclusion criteria (1 listed)
- chemoterapy without angiogenesis inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationAlso: clinical imagestreatment methods, associated symptoms, evolution and clinical presentation | Other | angiogenesis inhibitors |
Primary outcome
Benign migratory glossitis
Time frame: From enrollment to the end of study at 7 years
erythematous erosions, with loss of filiform papillae, surrounded by white circinate rims on the dorsal tongue
1 secondary outcome
Adverse events
Time frame: From enrollment to the end of study at 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio Neves Gomes, PhD principal investigator
Instituto do Cancer do Estado de São Paulo
Wagner Gomes da Silva, PhD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Geographic Tongue, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benign migratory glossitis (time frame: From enrollment to the end of study at 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.