Clinical trial NCT02602717: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Keywords: follicular origin
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: thyroglobin levels dosage
timeFrame: 7 days
Secondary outcomes:
measure: Plasma Tg levels
timeFrame: 7 days
measure: circulating anti-Tg antibodies levels
timeFrame: 7 days
measure: Detection of tumor cells by staining with May-Grünwald Giemsa of lymph node cytology elements :
timeFrame: 15 days
measure: Detection of tumors by lymph node histology
timeFrame: 15 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: APHM
name: Urielle Desalbres
role: STUDY_DIRECTOR
References: