Thyroid NoduleNCT05088187
Cognition and QoL After Thyroid Surgery
An observational study of Thyroid Nodule and Thyroid Cancer, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer, Cognitive Decline
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2023to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who are visiting the Medical Unit Endocrine Tumours at the Karolinska University Hospital and scheduled for thyroid surgery for Bethesda IV-VI thyroid lesions, will be informed about the possibility to participate in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cia Ihre Lundgren, MD Ass Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Medical Unit Breast-, Endocrine tumors and Sarcoma
Stockholm, 17176
Renske Altena, MD PhD, +46812375518, renske.altena@ki.se
About this study
Official title: Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
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.
Read the 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 pN0/x tumours), 3) patients in all other DTC risk groups (i.e., low, intermediate and high-risk). The primary comparison confers to groups 1 and 3.
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms, Cognitive Dysfunction, Neurobehavioral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS)
change in total score on ACS
Measured: pre-surgery to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start17 Jan 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Renske Altena, Karolinska University Hospital
- Investigators
- Renske Altena, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088187
- Sponsor's protocol ID
- CogniThyr
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share IPD upon request directly to the investigators
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05088187
- Acronym / sponsor ID
- CogniThyr
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pN0/x tumours), 3) patients in all other DTC risk groups (i.e., low, intermediate and high-risk). The primary comparison confers to groups 1 and 3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who are visiting the Medical Unit Endocrine Tumours at the Karolinska University Hospital and scheduled for thyroid surgery for Bethesda IV-VI thyroid lesions, will be informed about the possibility to participate in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS)
Time frame: pre-surgery to 12 months post-surgery
change in total score on ACS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Undecided. We plan to share IPD upon request directly to the investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cia Ihre Lundgren, MD Ass Professor contact
Renske Altena, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule and Thyroid Cancer, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renske Altena, MD PhD (+46724698719, renske.altena@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS) (time frame: pre-surgery to 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.