NCT05088187 Cognition and QoL After Thyroid Surgery
| NCT ID | NCT05088187 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Thyroid Nodule |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2023-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2023-01-17 with a primary completion date of 2023-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The development of cognitive dysfunction can profoundly affect HR-QoL as well as the possibility of societal participation and ability to work, and thereby relevantly impacts prospects for cancer survivorship. The aim of the study is to obtain improved understanding of the scope and magnitude of objective cognitive dysfunction in DTC survivors, and its relation to subjective cognitive dysfunction, thyroid hormone levels, physical activity and HRQoL. This is done in a prospective study where patients operated for a thyroid nodule (Bethesda IV-VI, i.e., benign \[goitre with nodule and fibroadenomas\], low-risk DTC and intermediate-high risk DTC) are included and asked to serially perform online neuropsychological testing as well as to complete questionnaires related to HR-QoL, physical activity and additional psychological and physical complaints. Blood is analysed for levels of thyroid hormones and systemic inflammation.
Eligibility Criteria
Inclusion Criteria: * Age \>18 years old, indication for surgery because of a thyroid nodule Bethesda IV-VI * Able to read and understand the Swedish language * Access to desktop computer or laptop with internet connection * Able and willing to provide written informed consent Exclusion Criteria: * A previous diagnosis of (auto-immune) hypothyroidism * A previous cancer diagnosis (excluding basal cell cancer of the skin) * Indications for surgery other than (solely) a thyroid nodule (i.e., concomitant Graves) * A diagnosis of medullary and anaplastic thyroid cancer
Contact & Investigator
Renske Altena, MD PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05088187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Nodule. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05088187 currently recruiting?
Yes, NCT05088187 is actively recruiting participants. Contact the research team at renske.altena@ki.se for enrollment information.
Where is the NCT05088187 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05088187 clinical trial?
NCT05088187 is sponsored by Karolinska University Hospital. The principal investigator is Renske Altena, MD PhD at Karolinska Institutet. The trial plans to enroll 320 participants.