Biopsy vs Active Monitoring for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine the better approach for managing potentially cancerous thyroid nodules: immediate biopsy or active monitoring. Immediate biopsy involves taking a small tissue sample right away to check for cancer. Active monitoring involves regularly checking the nodule with ultrasounds and doctor visits to observe any changes, performing a biopsy only if necessary. The trial seeks adults with a thyroid nodule likely to be cancerous, based on a specific ultrasound rating, who are considering a biopsy. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance future thyroid nodule management strategies.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that monitoring thyroid nodules is generally safe. One study found that patients with early thyroid cancer who were closely observed maintained stable health over 3.5 years. Another study in Europe found that monitoring was safe for nodules unlikely to be cancerous, with very low cancer-related deaths. Many guidelines now recommend monitoring as a viable alternative to immediate surgery for low-risk thyroid cancer.
These findings suggest that monitoring is well-tolerated and causes few serious side effects. This information can increase confidence in the safety of choosing monitoring to manage thyroid nodules.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores two different strategies for managing thyroid cancer: biopsy and active monitoring. Unlike the standard approach that often involves immediate biopsy and possibly surgery, active monitoring offers a less invasive alternative. It focuses on closely watching the thyroid nodule with regular ultrasounds and check-ups, potentially avoiding surgery and its associated risks and recovery time. This method could be beneficial for patients by reducing unnecessary procedures, and it allows for intervention only if changes are detected, which might improve overall patient quality of life.
What evidence suggests that this trial's treatments could be effective for managing thyroid nodules?
This trial will compare two approaches for managing thyroid nodules in low-risk thyroid cancer: immediate biopsy and active monitoring. Research has shown that monitoring thyroid nodules, small lumps in the thyroid gland, can be a safe and effective option for individuals with low-risk thyroid cancer. A review of several studies found that these lumps remained the same size over 3.5 years. Another study discovered that only 6% of nodules grew enough to require surgery. By actively monitoring, patients can avoid surgery and its side effects unless absolutely necessary. Many experts now view this as a viable alternative to immediate surgery for low-risk cases.12467
Who Is on the Research Team?
Louise Davies, MD, MS
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with thyroid nodules likely to be cancerous, based on ultrasound results. Participants must have a nodule ≤2 cm in diameter, be able and willing to consent (or have a surrogate who can), and are being considered for biopsy. Those with prior papillary thyroid cancer or without symptoms from the nodule can join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either immediate biopsy or active monitoring for thyroid nodules
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants continue with less frequent check-ups after the initial follow-up period
What Are the Treatments Tested in This Trial?
Interventions
- Active Monitoring
- Biopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
Dartmouth Cancer Center
Collaborator
American College of Radiology
Collaborator
Dartmouth College
Collaborator