NCT03699098

Brief Summary

This is a retrospective study with long term follow up to evaluate the incidence, timing and risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable head-and-neck-cancer

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

August 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

October 2, 2018

Last Update Submit

October 5, 2018

Conditions

Head and Neck Cancer

Keywords

hypothyroidismradiotherapyhead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • The the incidence of hypothyroidism

    Measuring the thyroid function tests

    8 months

Secondary Outcomes (1)

  • The risk factors of hypothyroidism

    8 months

Interventions

TSH, T3, T4 and thyroid gland DVHDIAGNOSTIC_TEST

measuring thyroid functions and DVH parameters of thyroid gland

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy

You may not qualify if:

  • Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of clinical oncology and nuclear medicine, Cairo university

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsHypothyroidism

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsThyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 9, 2018

Study Start

August 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 5, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)