Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05088187
Status:
RECRUITING
Last Update Posted:
2023-01-18
First Post:
2021-10-11
Brief Title:
Cognition and QoL After Thyroid Surgery
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Detailed Description:
The primary aim of this study is to prospectively assess objective cognitive functioning in patients undergoing thyroid surgery for different indications by means of an online neuropsychological test the Amsterdam Cognition Scale ACS
Three patient groups are defined 1 patients with follicular adenomas 2 patients with extreme low-risk differentiated thyroid cancer DTC pT1a and pN0x tumours 3 patients in all other DTC risk groups ie low intermediate and high-risk The primary comparison confers to groups 1 and 3
Three patient groups are defined 1 patients with follicular adenomas 2 patients with extreme low-risk differentiated thyroid cancer DTC pT1a and pN0x tumours 3 patients in all other DTC risk groups ie low intermediate and high-risk The primary comparison confers to groups 1 and 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None