Health TrialsbyHealthPanel

Active Surveillance of Papillary Thyroid Microcarcinoma

ConditionPapillary Thyroid Microcarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation.

2.0 cm or smaller nodules by ultrasonographic criteria

Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form

Must be able to read and write English fluently to participate in the questionnaire portion of the study

Disqualifiers

High-grade or poorly differentiated PTC variants

Central or lateral neck lymphadenopathy suspicious for PTC

Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)

History of radiation to neck

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Surveillance

    Other intervention

    Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Active SurveillanceOther 1 intervention
Group B: Immediate SurgeryNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of disease progression

Time frame
From time of diagnosis up to10 years of follow-up

Secondary outcomes

1

Percentage of subjects that will elect surgery despite absence of clinical progression

Time frame
From time of diagnosis up to 10 years of follow-up
2

Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound

Time frame
Five years
3

Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance

Time frame
Five years
4

Identify the genetic factors associated with an increased risk of disease progression

At any time subjects who have enrolled in the active surveillance study can opt to have surgery. Data will be taken from diagnosis to just after surgery.

Time frame
Five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
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