Tiroid Karsinomunun Moleküler Karakterizasyonu için İspanya Çalışması

Sade dilde özet

Bu çalışma, tiroid karsinomunun (thyroid carcinoma) moleküler özelliklerini, immünohistokimya, FISH ve 52 gen içeren bir test paneli ile inceleyip haritalamayı amaçlıyor. Çalışmaya, radyoaktif iyoda dirençli diferansiye tiroid karsinomu ya da medüller tiroid karsinomu olan, ilerlemiş/metastatik hastalığı bulunan 18 yaş üzeri hastalar alınmaktadır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Devam ediyor, katılım kapalı

Sponsor

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Müdahale

Immunohistochemistry (IHC), Fluorescence In-Situ Hybridization (FISH), Oncomine Focus Assay Platform with 52 genes

Başlangıç

14.06.2021

Tahmini bitiş

01.03.2025

Ülkeler

Spain

İlgili genler

Merkezler

• Barcelona, Spain
• Barcelona, Spain
• L'Hospitalet de Llobregat, Spain
• Manresa, Spain
• Sabadell, Spain
• Santander, Spain
• Girona, Spain
• Madrid, Spain
• Madrid, Spain
• Valencia, Spain
• Valencia, Spain
• Zaragoza, Spain

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. All participants must be over 18 years old
2. Obtaining the informed consent signed by the patient or his legal representative.
3. Have a paraffinized tumor sample available for analysis in the central laboratory, preferably from total thyroidectomy.
4. Life expectancy greater than 6 months.
5. Thyroid carcinoma with a date of initial histological diagnosis before January 1, 2021 of the types:

(1) Differentiated thyroid carcinoma (DTC) refractory to radio-iodine, including papillary carcinomas, follicular carcinomas, poorly differentiated thyroid carcinomas, and the corresponding different variants. The radio-refractoriness criteria will be defined by medical criteria and / or by decision of the tumor committee (depending on the organization of each hospital) or (2) Medullary thyroid carcinoma (MTC). 6. Potential candidate patients must meet at least one of the following premises:

1. Patients with advanced / metastatic disease in wait \& see follow-up.
2. Patients with advanced / metastatic disease currently undergoing treatment or in progression to any type of multikinase inhibitor, such as, for example: sorafenib, lenvatinib, cabozantinib, axitinib, vandetanib, ...
3. Patients with advanced / metastatic disease under treatment or in progression to treatments that inhibit immune checkpoints (anti programed death (PD-1) or its ligand (PD-L1), anti Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), others) or who are participating in clinical trial regimen. They must be patients who have previously progressed to multikinase inhibitors.

Exclusion Criteria:

1. Patients affected by other malignant histologies not mentioned in the previous section (eg melanoma, lymphoma, sarcoma, ...) or benign tumors exclusively of the thyroid gland.
2. Patients with radioiodine sensitive differentiated thyroid carcinoma or anaplastic thyroid carcinomas.
3. Patients with refractory radioiodine differentiated thyroid carcinoma and advanced medullary thyroid carcinomas with the possibility of local ablative treatment with radical or curative intent (surgery, radiosurgery, radio-ablation, ...).