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
Trial Overview
The study compares immediate biopsy versus active monitoring of thyroid nodules suspected of being cancerous. It aims to assess participants' anxiety using Anxiety-CA and their quality of life related to the thyroid after 6 months, by randomly assigning them into one of these two management strategies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently. If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects.
The aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that. If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above.
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
Citations
Active Surveillance in Early Thyroid Cancer: A Meta-Analysis
It was shown that AS in patients with early thyroid cancer has a stable tumor progression outcome over a 3.5-year period of AS and has a high ...
Active Surveillance Program in Thyroid Nodules
The results showed a growth rate of 21%, with only 6% of the nodules showing growth greater than 50%, and these patients were taken to surgery. García-Lozano ...
Active Surveillance of Papillary Thyroid Cancer
Active surveillance is considered a safe and effective management option for properly selected patients with low-risk papillary thyroid cancer (PTC). These ...
Active Surveillance for Low-Risk Thyroid Cancers
Many practice guidelines have adopted active surveillance as a feasible alternative to immediate surgery for low-risk thyroid cancer.
Active surveillance for well-differentiated thyroid cancer
While there are minor differences in inclusion criteria, the primary outcomes are tumor size progression and lymph node metastasis as shown in Table 1.
6.
thyroid.org
thyroid.org/patient-thyroid-information/ct-for-patients/september-2023/vol-16-issue-9-p-3-4/Active surveillance vs surgery in adults with low risk ...
57.1% underwent active surveillance for a year or longer, while 42.9% underwent surgery within 1 year of their diagnosis. The average duration of active ...
Expanded Parameters in Active Surveillance for Low-risk ...
The study results suggest that a more permissive active surveillance strategy that encompasses most diagnosed thyroid cancer appears viable.
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