NCT03889769

Brief Summary

The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Recently, new molecular biologic techniques, such as One Step Nucleic Acid Amplification (OSNA), have spread widely, allowing to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19. The aim of this study is to evaluate the application of OSNA to intraoperative diagnosis of node metastases of PTC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

March 23, 2019

Last Update Submit

March 23, 2019

Conditions

Papillary Thyroid CancerLymph Node Metastases

Outcome Measures

Primary Outcomes (1)

  • Accuracy of OSNA

    Measurement of OSNA accuracy

    1 day

Interventions

OSNA testDIAGNOSTIC_TEST

Analysis of lymph node with OSNA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with preoperative cytological diagnosis of papillary thyroid carcinoma (Tir4-Tir5)

You may qualify if:

  • Preoperative diagnosis of thyroid carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico di Monserrato

Monserrato, Cagliari, 09040, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryLymphatic Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pietro Giorgio Calò

    University of Cagliari

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Medas

CONTACT

+393206836288fabiomedas@gmail.com

Fabio Medas

CONTACT

+3951096288fabiomedas@unica.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 26, 2019

Study Start

December 20, 2016

Primary Completion

April 1, 2019

Study Completion

September 30, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

IT(1)