NCT04270201

Brief Summary

A case-control study with oral squamous cell carcinoma (OSCC) patients from Instituto do Câncer do Estado de São Paulo (ICESP) and healthy volunteers. In this study, it will be collected saliva samples from both groups that will be submitted to sequencing analysis to evaluate the frequency of ALDH1b1 and ALDH2 polymorphisms in the Brazilian population. Also, correlate OSCC risk to alcohol consumption or smoke, by applied questionnaires.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

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

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 2, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

February 12, 2020

Last Update Submit

May 17, 2021

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Oral squamous cell carcinomaALDH1b1ALDH2polymorphism

Outcome Measures

Primary Outcomes (1)

  • Frequency of ALDH1b1 and ALDH2 polymorphisms

    Determine the frequency of ALDH1b1 and ALDH2 polymorphisms in OSCC patients and healthy volunteers.

    1 year

Secondary Outcomes (1)

  • Survival

    5 years

Study Arms (2)

Case group

OSCC patients (n = 60)

Other: Saliva collection

Control group

Healthy volunteers (n = 240)

Other: Saliva collection

Interventions

Saliva collectionOTHER

Saliva collection

Case groupControl group

Eligibility Criteria

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

OSCC patients (n = 60) and healthy volunteers (n = 240) matched by age and sex.

You may qualify if:

  • OSCC diagnostic for case group
  • Able to read and sign the consent form.
  • Able for saliva collection.
  • Able to understand the applied questionnaires.

You may not qualify if:

  • Unable to read and sign the consent form.
  • Unable for saliva collection.
  • Unable to understand the applied questionnaires.
  • OSCC patient's companions for healthy volunteers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Gilberto de Castro Junior, MD, PhD

    Instituto do Câncer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabela C de Souza

CONTACT

+5511982496744isabelasouza@usp.br

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

January 2, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations

BR(1)