NCT02742363

Brief Summary

The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence. The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood. Materials and methods:

  • Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
  • The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration 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

First Submitted

Initial submission to the registry

March 23, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

March 23, 2016

Last Update Submit

January 18, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Oral abnormalities associated with cancer therapy.

    A medical survey will be filled out with the patient and his legal guardian. A full dental examination will gather all clinical and radiographic findings. The following measures will be noted: 1. Description of chemotherapy agents and duration 2. Radiotherapy continuation. 3. Radiotherapy dosage in Gray units. 4. Yes/No questions regarding previous dental trauma. 5. Yes/No questions regarding previous dental treatment. 6. Questions regarding oral hygiene. 7. Questions concerning oral habits. 8. Extra oral examination. 9. Intra oral clinical findings will be listed by tooth number. 10. Radiographic findings will be listed by tooth number.

    Two years

Interventions

Collecting dataOTHER

Collecting data from patient records

Eligibility Criteria

Age12 Years - 32 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The maximum time span of entering the study group-up to 20 years after last session of oncology treatment.

You may qualify if:

  • were treated for Cancer at the age of 0-10 years old

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 19, 2016

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

IL(1)