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Trial Title:
Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer
NCT ID:
NCT06111430
Condition:
Radiation Treatment
Neurovascular Complications
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland,
mucosa of the upper respiratory or digestive system covering the oral and nasal cavity.
Radiotherapy is usually the standard treatment of Head and neck cancers. In the present
study, investigators aim to study the prevalence of cervical-cranial vascular
complications during the early stages in these Head and neck cancer patients receiving
Radiotherapy. Investigators will also compare the results between Nasopharyngeal cancer
and other Head and neck cancerpatients receiving Radiotherapy.
Criteria for eligibility:
Study pop:
The study population will comprise Head and neck cancer patients recruited in the
prospective and retrospective cohorts. The Head and neck cancer patients in this study
indicates those coded with ICD 10 (C00-13, C30-32). The coordinating center (Linkou
medical center) will establish periodic communications through email and newsletters with
participating sites (Keelung branch, Chia-yi branch, and etc.) to ensure data
completeness and reduce the odds of loss-to follow-up of patients. We will aim to
minimize data queries as much as possible, by prioritizing the completeness of the most
relevant data for evaluating the main registry outcomes. We plan to follow up the
patients until after 120 months after radiotherapy.
Sampling method:
Non-Probability Sample
Criteria:
Population: Prospective cohort
Inclusion Criteria:
1. Age ≥20 years.
2. Head and neck cancer patient .
3. Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the
registry.
4. Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and
d date of enrolment.
Exclusion Criteria:
1. Age <20 years.
2. Patients not willing to sign the informed consent.
Population: Retrospective validation cohort
Inclusion Criteria:
1. Age ≥20 years.
2. Head and neck cancer patient.
3. Had ever received radiation therapy (RT) > 120 months before the adoption date of
IRB at the participant site.
4. Had ≥ 2 brain images and cervical-cranial vascular studies between the end of RT and
6~10 years after RT, one within 5 years after RT, the other after 5 years after RT.
Exclusion Criteria:
1.Age <20 years.
Gender:
All
Minimum age:
20 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Memorial Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chi-Hung Liu
Phone:
033281200
Phone ext:
8340
Email:
ivanliu001@cgmh.org.tw
Contact backup:
Last name:
Hui-Ching Kang
Phone:
033281200
Phone ext:
5214
Email:
karen0201kang@gmail.com
Start date:
April 11, 2022
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06111430
