NCT02814032

Brief Summary

Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid carcinoma patients. This study aim to reveal protein expression differences between papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis.

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
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 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

June 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

7.5 years

First QC Date

June 23, 2016

Last Update Submit

July 18, 2023

Conditions

Papillary Thyroid Carcinoma

Keywords

proteomiccervical lymph node metastasis

Outcome Measures

Primary Outcomes (1)

  • differences in protein expression

    6 months

Study Arms (4)

PTC group 1

papillary thyroid carcinoma patients with cervical lymph node metastasis

PTC group 2

papillary thyroid carcinoma patients without cervical lymph node metastasis

Positive control group

benign disease

Negative control group

histologically normal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-65 years; newly diagnosed papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.

You may qualify if:

  • Newly diagnosed papillary thyroid carcinoma.
  • Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer.

You may not qualify if:

  • Current substance abuse/dependence.
  • Daily tobacco and alcohol use.
  • Whole neck irradiation or surgery.
  • Prior cancer diagnosis or chemotherapy treatment.
  • Active autoimmune disorder.
  • Uncontrolled allergic condition or asthma.
  • Chronic use of oral steroid medication.
  • Hormone therapy (estrogen, progestin compounds).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shan Jin

Hohhot, Inner Mongolia, 010050, China

RECRUITING

Related Publications (4)

  • Gharib H, Papini E. Thyroid nodules: clinical importance, assessment, and treatment. Endocrinol Metab Clin North Am. 2007 Sep;36(3):707-35, vi. doi: 10.1016/j.ecl.2007.04.009.

    PMID: 17673125BACKGROUND

  • Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

    PMID: 26462967BACKGROUND

  • Brown LM, Helmke SM, Hunsucker SW, Netea-Maier RT, Chiang SA, Heinz DE, Shroyer KR, Duncan MW, Haugen BR. Quantitative and qualitative differences in protein expression between papillary thyroid carcinoma and normal thyroid tissue. Mol Carcinog. 2006 Aug;45(8):613-26. doi: 10.1002/mc.20193.

    PMID: 16788983BACKGROUND

  • Sofiadis A, Becker S, Hellman U, Hultin-Rosenberg L, Dinets A, Hulchiy M, Zedenius J, Wallin G, Foukakis T, Hoog A, Auer G, Lehtio J, Larsson C. Proteomic profiling of follicular and papillary thyroid tumors. Eur J Endocrinol. 2012 Apr;166(4):657-67. doi: 10.1530/EJE-11-0856. Epub 2012 Jan 24.

    PMID: 22275472BACKGROUND

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Shan Jin, PhD

    The Affiliated Hospital of Inner Mongolia Medical University

    STUDY DIRECTOR

Central Study Contacts

Shan Jin, PhD

CONTACT

+86-15849338280jinshangood@163.com

Yun-tian Yang, PhD

CONTACT

+86-15849338737yangyuntian@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 27, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

CN(1)