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.

NCT07822217 | Active Not Recruiting DMC

• 2 other identifiers: 1-10-72-170-25VEK-number: 1-10-72-170-25
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer; Active Surveillance

Outcome Measures

Primary Outcomes (1)

• Treatment

  The need for treatment due to tumor growth within 24 months (cumulative incidence)

  24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Otorhinolaryngology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2034
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

DK (1)