Patients With a Single, Small (2 cm or Less) Cancer Nodule in the Thyroid Gland Will be Offered Active Surveillance Initially for 5 Years. In Case of Cancer Growth or Changes in Ultrasonographic Appearance, Further Treatment Will be Offered.

September 10, 2026 updated by: University of Aarhus

Active Surveillance of Small Thyroid Cancers.

Patients with a single, small (less than 2 cm) cancer nodule in the thyroid gland will be offered active surveillance initially for 5 years. In case of cancer growth or changes in ultrasonographic appearance, further treatment will be offered.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Otorhinolaryngology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of 30 years or older with small, low-risk cancers in the thyroid gland.

Description

Inclusion criteria:

  • age of 30 years or older AND
  • single, well-defined tumor in the thyroid gland, with a FNAB suspicious of cancer or diagnostic of cancer (category V or VI in the Bethesda system) AND
  • tumor size of 2 cm or less in all dimensions.

Exclusion criteria:

  • suspicion of disseminated disease because of:

    • PET-positive lymph nodes on the neck
    • suspicious lymph-nodes by neck ultrasonography (US)
    • signs of capsular invasion of the tumor
    • suspicion of metastatic disease due to findings on PET-CT-scan or thoracic CT-scan; OR
  • tumor placement at a high-risk location (in the thyroid capsule or near the trachea) OR
  • previous thyroid surgery OR
  • concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol/L) OR
  • if the patient is pregnant OR
  • If the patient is unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Active surveillance
Above 30 years-of-age; one tumor suspicious for or diagnosed with malignancy (BSRTC V/VI); tumor 2 cm or less in widest diameter; cN0 and cM0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment
Time Frame: 24 months
The need for treatment due to tumor growth within 24 months (cumulative incidence)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

February 28, 2031

Study Completion (Estimated)

February 28, 2034

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-170-25
  • VEK-number: 1-10-72-170-25 (Other Identifier: De Videnskabsetiske Komitéer For Region Midtjylland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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