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Active Surveillance for Thyroid Cancer (PMCAS Trial)

N/A
Recruiting
Led By Allen Ho, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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
Must not have
Central or lateral neck lymphadenopathy suspicious for PTC
History of radiation to neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether active surveillance is better than surgery for people with a small thyroid cancer.

Who is the study for?
This trial is for individuals with small thyroid nodules (2.0 cm or smaller) diagnosed as papillary thyroid carcinoma, who can read and write English fluently for questionnaires. It's not suitable for those with unfavorably located nodules, a history of neck radiation, aggressive cancer variants, or suspicious lymphadenopathy.
What is being tested?
The study is examining the outcomes of monitoring patients with papillary thyroid microcarcinoma through active surveillance instead of immediate surgery to see if waiting and watching could be safe and effective.
What are the potential side effects?
Since this trial involves active surveillance rather than medication or surgical intervention, there are no direct side effects from treatments being tested; however, anxiety or stress related to ongoing monitoring may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My thyroid nodules are confirmed to be at high risk for cancer or have a BRAF mutation.
Select...
My thyroid nodules are confirmed to be at high risk for cancer or have a BRAF mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have swollen lymph nodes in my neck that may indicate thyroid cancer.
Select...
I have had radiation treatment to my neck.
Select...
My thyroid cancer is a high-grade or poorly differentiated type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Identify the genetic factors associated with an increased risk of disease progression

Side effects data

From 2020 Phase 2 trial • 227 Patients • NCT02799745
55%
Fatigue
38%
Gynaecomastia
30%
Nipple pain
26%
Breast tenderness
20%
Erectile dysfunction
10%
Upper respiratory tract infection
10%
Alopecia
9%
Libido decreased
9%
Back pain
9%
Hypertension
9%
Arthralgia
7%
Pollakiuria
6%
Nausea
6%
Breast enlargement
5%
Dysuria
5%
Weight decreased
5%
Weight increased
5%
Hot flush
5%
Diarrhoea
3%
Myocardial infarction
2%
Escherichia sepsis
2%
Pneumonia
1%
Hip fracture
1%
Cervical spinal stenosis
1%
Cholangiocarcinoma
1%
Osteoarthritis
1%
Acute kidney injury
1%
Spinal stenosis
1%
Haemorrhage intracranial
1%
Central cord syndrome
1%
Suicide attempt
1%
Pneumothorax
1%
Deep vein thrombosis
1%
Rib fracture
1%
Non-Hodgkin's lymphoma
1%
Accidental death
1%
Electroencephalogram abnormal
1%
Prostatitis
1%
Arteriospasm coronary
1%
Vertigo positional
1%
Enteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide
Active Surveillance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active SurveillanceExperimental Treatment1 Intervention
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.
Group II: Immediate SurgeryActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
163,173 Total Patients Enrolled
Allen Ho, MDPrincipal Investigator - Cedars-Sinal Medical Center
Cedars-Sinai Medical Center
Medical School - Medical College of Wisconsin, Doctor of Medicine
Cedars-Sinai Medical Center, Residency in Internal Medicine
3 Previous Clinical Trials
199 Total Patients Enrolled

Media Library

Active Surveillance Clinical Trial Eligibility Overview. Trial Name: NCT02609685 — N/A
Thyroid Cancer Research Study Groups: Active Surveillance, Immediate Surgery
Thyroid Cancer Clinical Trial 2023: Active Surveillance Highlights & Side Effects. Trial Name: NCT02609685 — N/A
Active Surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT02609685 — N/A
~88 spots leftby Dec 2030
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