The Evaluation of the Diagnostic Properties of Intra-operative In-situ Thyroglobin Levels of Cervical Lymph Nodes, in the Discrimination Between Benign and Malignant Lymph Nodes in Thyroid Cancer: a Prospective Multicentre Study.

NCT ID: NCT02602717

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-18
• Study Completion Date: 2018-12-31

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.

Conditions

Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

thyroid cancer

Group Type: EXPERIMENTAL

lymph nodes cyto-punction

Intervention Type: OTHER

Interventions

lymph nodes cyto-punction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Subjects presenting with thyroid cancers of non follicular origin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle Desalbres

Role: STUDY_DIRECTOR

APHM

Locations

APHM

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

cecile Colavolpe, MD

Role: CONTACT

cecile.colavolpe@ap-hm.fr

Facility Contacts

cecile colavolpe, MD

Role: primary

cecile.colavolpe@ap-hm.fr

Other Identifiers

RC12_3625

Identifier Type: OTHER

Identifier Source: secondary_id

2012-06

Identifier Type: -

Identifier Source: org_study_id