Clinical trial NCT06111430: Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer
Official title: The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation Treatment
Neurovascular Complications
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Significant CAS at internal carotid artery or common carotid artery
timeFrame: 1 year
measure: Cerebral infarctions (CI)
timeFrame: 1 year
measure: Significant extracranial vertebral artery stenosis (VAS)
timeFrame: 1 year
measure: Significant intracranial artery stenosis
timeFrame: 1 year
measure: Presence of carotid blow-out syndrome
timeFrame: 1 year
measure: Presence of TLN
timeFrame: 1 year
measure: Presence of hypothyroidism
timeFrame: 1 year
measure: Tumor recurrence
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: