Informations générales (source: ClinicalTrials.gov)
(Tgcyto)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
février 2013
décembre 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| APHM - Marseille - France | cecile colavolpe, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- Subjects presenting with thyroid cancers of non follicular origin