20 Participants Needed

Biopsy vs Active Monitoring for Thyroid Cancer

TS
JR
MM
Overseen ByMichaela M Geffert, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

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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

I can give my consent or have someone who can consent for me.
I am being considered for a biopsy.
I have had papillary thyroid cancer in the past.
See 8 more

Exclusion Criteria

My thyroid gland has been removed.
Patients who have already had a biopsy of the nodule being considered for inclusion in the study
Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either immediate biopsy or active monitoring for thyroid nodules

6 months
Regular check-ups every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Check-ups every 6 months

Long-term follow-up

Participants continue with less frequent check-ups after the initial follow-up period

Ongoing

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?
2Treatment groups
Experimental Treatment
Group I: Immediate biopsy (usual care)Experimental Treatment1 Intervention
Group II: Active monitoring, proceeding to biopsy if neededExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Dartmouth Cancer Center

Collaborator

Trials
3
Recruited
260+

American College of Radiology

Collaborator

Trials
24
Recruited
8,055,000+

Dartmouth College

Collaborator

Trials
93
Recruited
1,415,000+

Citations

Active Surveillance in Early Thyroid Cancer: A Meta-AnalysisIt 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 NodulesThe 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 CancerActive 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 CancersMany practice guidelines have adopted active surveillance as a feasible alternative to immediate surgery for low-risk thyroid cancer.
Active surveillance for well-differentiated thyroid cancerWhile there are minor differences in inclusion criteria, the primary outcomes are tumor size progression and lymph node metastasis as shown in Table 1.
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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