NCT02602717

Brief Summary

Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses. To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.

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
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

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

February 18, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

October 22, 2015

Last Update Submit

July 24, 2018

Conditions

Thyroid Cancer

Keywords

follicular origin

Outcome Measures

Primary Outcomes (1)

  • thyroglobin levels dosage

    7 days

Secondary Outcomes (4)

  • Plasma Tg levels

    7 days

  • circulating anti-Tg antibodies levels

    7 days

  • Detection of tumor cells by staining with May-Grünwald Giemsa of lymph node cytology elements :

    15 days

  • Detection of tumors by lymph node histology

    15 days

Study Arms (1)

thyroid cancer

EXPERIMENTAL
Other: lymph nodes cyto-punction

Interventions

lymph nodes cyto-punctionOTHER
thyroid cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject aged 18 years and above, male or female, with a valid social security coverage;
  • Subject willing to participate in the study with a signed informed consent;
  • Subject being operated for a papillary thyroid cancer, re-operated for persistent/relapsed lymphadenopathy, or for benign thyroid pathology (Graves disease, multinodular goitre, toxic nodule);
  • Subject having had a blood test for plasma Tg levels and circulating anti-Tg antibodies in the week preceding the surgical intervention.

You may not qualify if:

  • \- Subjects presenting with thyroid cancers of non follicular origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHM

Marseille, France

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Urielle Desalbres

    APHM

    STUDY DIRECTOR

Central Study Contacts

cecile Colavolpe, MD

CONTACT

cecile.colavolpe@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

November 11, 2015

Study Start

February 18, 2013

Primary Completion

May 17, 2017

Study Completion

December 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

FR(1)