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NCT02408887 · ClinicalTrials.gov registry record · Phase 2
Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02408887: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02408887 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408887, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Background: \- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: \- To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid. Eligibility: \- Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body. Design: * Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays. * Participants will: * Answer questions. They may have a tumor biopsy. * Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords. * Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread. * Group 2: have surgery to remove the thyroid and lymph nodes in the neck. * At all post-surgery visits, participants will answer questions and have blood drawn. In addition: * 1 day: laryngoscopy. * 2 weeks: possible laryngoscopy. * 3 months: ultrasound of the thyroid and neck. * Discuss whether to try hormone treatment and/or radioactive iodine. * Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera. * 6 months: ultrasound and maybe laryngoscopy. * 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone. * Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.
Primary Outcome
number of participants that have biochemical cure after total thyroidectomy (TT) with and without pCND as measured by postoperative thyroid stimulating hormone (TSH)-stimulated serum thyroglobulin (stim-Tg). Per protocol, Biochemical cure is defined as "stim-Tg \< 2 ng/ml or unstimulated Tg ≤ 0.2 ng/ml" post-surgery. Biochemical persistent or recurrent disease is suspected when stim-Tg ≥5 ng/ml or unstimulated Tg \>0.3 ng/ml or a conversion or a rise in anti-Tg antibodies.
Interventions
- PROCEDURE Total Thyroidectomy (TT)
- PROCEDURE Prophylactic central neck lymph node dissection (pCND)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-04-15 |
| Est. Completion | 2019-05-07 |
| Phase | Phase 2 |
Why NCT02408887 stopped before completion
NCT02408887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Total Thyroidectomy (TT) is the first listed.
NCT02408887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02408887 about?
NCT02408887 is a clinical study titled "Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer". Background: \- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: \- To compare the effectiveness of removing lymph nodes in the neck th...
What is the current status of trial NCT02408887?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-04-15. Estimated completion is 2019-05-07.
What interventions are being tested in trial NCT02408887?
The interventions under investigation include: Total Thyroidectomy (TT) (PROCEDURE), Prophylactic central neck lymph node dissection (pCND) (PROCEDURE).
Who is sponsoring clinical trial NCT02408887?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02408887's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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