Active Surveillance of Papillary Thyroid Microcarcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT02609685
Status
Recruiting
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Conditions

  • Papillary Thyroid Microcarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 13, 2016
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
216 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Active Surveillance
    Active surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter.
  • No Intervention: Immediate Surgery
    Patients who choose to get surgery immediately after diagnosis may choose to enroll in a questionnaire sub-study that will compare quality of life and anxiety scores to patients who enroll in the active surveillance study. This is considered "no intervention" because the protocol is not directing treatment. Surgery is the standard treatment for papillary thyroid microcarcinoma.

Primary Outcome Measure

Rate of disease progression [ Time Frame: From time of diagnosis up to10 years of follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Allen Ho, MD
[email protected]
310-423-1220
Allen Ho, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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