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. (Tgcyto)
Primary Purpose
Thyroid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
lymph nodes cyto-punction
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Cancer focused on measuring follicular origin
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
Sites / Locations
- APHMRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
thyroid cancer
Arm Description
Outcomes
Primary Outcome Measures
thyroglobin levels dosage
Secondary Outcome Measures
Plasma Tg levels
circulating anti-Tg antibodies levels
Detection of tumor cells by staining with May-Grünwald Giemsa of lymph node cytology elements :
Detection of tumors by lymph node histology
Full Information
NCT ID
NCT02602717
First Posted
October 22, 2015
Last Updated
July 24, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02602717
Brief Title
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.
Acronym
Tgcyto
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2013 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
follicular origin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thyroid cancer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
lymph nodes cyto-punction
Primary Outcome Measure Information:
Title
thyroglobin levels dosage
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Plasma Tg levels
Time Frame
7 days
Title
circulating anti-Tg antibodies levels
Time Frame
7 days
Title
Detection of tumor cells by staining with May-Grünwald Giemsa of lymph node cytology elements :
Time Frame
15 days
Title
Detection of tumors by lymph node histology
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cecile Colavolpe, MD
Email
cecile.colavolpe@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
APHM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cecile colavolpe, MD
Email
cecile.colavolpe@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
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.
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