NCT01417442

Brief Summary

The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

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
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for early_phase_1

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

July 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

July 6, 2011

Last Update Submit

August 13, 2011

Conditions

Papillary Thyroid Carcinoma

Keywords

papillary thyroid carcinomaBRAF V600Epoor prognosisaggressive

Outcome Measures

Primary Outcomes (1)

  • BRAF V600E MUTATION

    2 years

Study Arms (1)

BRAF V600E POSITIVITY

EXPERIMENTAL

This mutation will be analysed using the tumor tissues of the patients operated for thyroid diseases and diagnosed with papillary thyroid carcinoma. And mutation positive patients will be investigated for the aggressive characteristics of the tumor.

Genetic: BRAF V600E POSITIVITY

Interventions

BRAF V600E POSITIVITYGENETIC

BRAF V600E mutation analysis will be made using the tumor tissues of the patients with papillary thyroid cancer (3 sections of 7 mm from he paraffin blocks). And mutation positives and negatives will be identified.

BRAF V600E POSITIVITY

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with papillary thyroid cancer

You may not qualify if:

  • Patients who do not want to be a part of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeliz Emine Ersoy

Istanbul, Istanbul, 34308, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryAggression

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2011

First Posted

August 16, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

TU(1)