NCT02323724

Brief Summary

To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

December 18, 2014

Last Update Submit

September 21, 2016

Conditions

Papillary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Improvement in diagnosis

    To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).

    6 months

Study Arms (1)

Selected Papillary carcinoma

Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.

Genetic: BRAF V600E mutation by pyrosequencing technique

Interventions

BRAF V600E mutation by pyrosequencing techniqueGENETIC
Selected Papillary carcinoma

Eligibility Criteria

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

Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí

You may qualify if:

  • Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí

You may not qualify if:

  • Non available cytological or histological material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Pathology

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

ES(1)