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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights
PMCAS Trial 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.Check my eligibility
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.See study design
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.
PMCAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PMCAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of disease progression
Secondary outcome measures
Anxiety score as measured by Memorial Anxiety Scale
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Identify the genetic factors associated with an increased risk of disease progression
+3 moreSide effects data
From 2020 Phase 2 trial • 227 Patients • NCT027997459%
Hypertension
5%
Upper respiratory tract infection
4%
Fatigue
4%
Arthralgia
4%
Back pain
4%
Dysuria
4%
Pollakiuria
4%
Erectile dysfunction
3%
Gynaecomastia
2%
Weight decreased
1%
Angina pectoris
1%
Atrial fibrillation
1%
Cardiac tamponade
1%
Coronary artery perforation
1%
Abdominal pain
1%
Chronic sinusitis
1%
Basal cell carcinoma
1%
Bladder transitional cell carcinoma
1%
Malignant pleural effusion
1%
Haemorrhagic stroke
1%
Movement disorder
1%
Presyncope
1%
Pulmonary mass
1%
Physical disability
1%
Diarrhoea
1%
Nausea
1%
Libido decreased
1%
Breast tenderness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Surveillance
Enzalutamide
PMCAS 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
499 Previous Clinical Trials
164,641 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swollen lymph nodes in my neck that may indicate thyroid cancer.My tumor is located in a risky area near important neck structures.My thyroid nodules are confirmed to be at high risk for cancer or have a BRAF mutation.I have had radiation treatment to my neck.My thyroid cancer is a high-grade or poorly differentiated type.My thyroid nodules are confirmed to be at high risk for cancer or have a BRAF mutation.Nodules in the body that are 2.0 cm or smaller according to ultrasound measurements.
Research Study Groups:
This trial has the following groups:- Group 1: Active Surveillance
- Group 2: Immediate Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are actively engaged in this research endeavor?
"Affirmative. The data hosted on clinicaltrials.gov affirms that this experimental project, which was first launched on May 13th 2016, is currently recruiting participants. Approximately 216 volunteers should be sourced from 1 medical institution."
Answered by AI
Is enrolling still open for this trial?
"Per the clinicaltrials.gov listing, this medical trial is actively enrolling patients. Initially posted on May 13th 2016, it was most recently updated July 5th 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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