NCT02862470

Brief Summary

The investigators expected to enroll 30 patients with papillary, follicular or anaplastic thyroid cancer, and collect their urine samples before operation, immediately after operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal proteins and probable biological markers. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic mechanism and medications for such patients with poorly-differentiated or anaplastic thyroid cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Status
completed

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

First Submitted

Initial submission to the registry

July 27, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

August 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2020

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 27, 2016

Last Update Submit

July 2, 2021

Conditions

Keywords

LovastatinVildagliptinExosomeAnaplastic thyroid cancerProteomicsUrineBiological marker

Outcome Measures

Primary Outcomes (1)

  • Prognostic biological markers via this prospective study.

    Our study was designed as prospective pattern, and the investigators enrolled new thyroid cancer with follow-up, then detect urine exosome and proteins. The investigators try to find the correlation of outcome ( including recurrence, lymph nodes metastasis..) together with unknown/fresh biomarkers in this study and time-dependent manner.

    2 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators will enroll the newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer. After signing inform consent, the investigators will collect their urine samples before operation, immediately after operation, post-operative 3, 6 12 months (5 times in one patient).

You may qualify if:

  • Newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer

You may not qualify if:

  • Thyroid papillary, follicular and anaplastic thyroid cancer with prior operation, chemotherapy, or isotope treatment, or target therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huang TY, Wang CY, Chen KY, Huang LT. Urinary Exosomal Thyroglobulin in Thyroid Cancer Patients With Post-ablative Therapy: A New Biomarker in Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Jun 16;11:382. doi: 10.3389/fendo.2020.00382. eCollection 2020.

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • CHIH-YUAN WANG, Doctor

    Department of Internal Medicine, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
52 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 11, 2016

Study Start

August 5, 2016

Primary Completion

October 1, 2018

Study Completion

August 24, 2020

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share