Cholesterol Metabolites Analysis in Human Thyroid and Iodine Resistance

Thyroid Cancer Clinical Trial

— OXYTHYR  

Official title:

Cholesterol Metabolites (Dendrogenin A or DDA, 6-oxo-cholestane-3β,5α-diol or OCDO,...) Quantification in Malignant Versus Normal Human Thyroid Tissue Refractory to Iodine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821336
• Other study ID #: 21HLVADS01
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study team previously shown that a cholesterol metabolite, dendrogenin A (DDA) differentiates anaplastic thyroid cancer cell lines and that its mRNA expression is diminished in human radioiodine refractory thyroid cancer samples. The team aim to quantify via mass spectrometry and immunohistochemistry DDA and other cholesterol metabolites in thyroid cancer versus healthy thyroid tissue human samples.

Description:

Retrospective study to analyze tissue samples of patients after thyroid surgery at Claudius Regaud Institute Toulouse, France, for thyroid cancer or thyroid aggressive lymphoma or benign thyroid pathology or other head&neck pathology necessitating total thyroidectomy despite normal thyroid.

Analysis focused on cholesterol metabolites quatification by mass spectrometry in liquid and gas phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have undergone surgery at Institut Claudius Regaud for thyroid or laryngeal cancer confirmed by histology.

• Patients who have consented before surgery, for the use of participants samples for future researches.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Metabolites dosage
On samples investigators will quantify cholesterol metabolite and dendrogenin A (DDA) and 6-oxo-cholestane-3ß,5a-diol (ou OCDO) metabolites in malignant tissue sample on one hand, and in sane samples on other hand. The investigators will compare the rate of deregulation between sane and malignant ones.

Locations

Country	Name	City	State
France	Institut Claudius regaud IUCT Oncopole	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Cancer Research Center of Toulouse

Country where clinical trial is conducted

France, 

References & Publications (10)

de la Fouchardiere C, Alghuzlan A, Bardet S, Borget I, Borson Chazot F, Do Cao C, Godbert Y, Leenhardt L, Zerdoud S, Leboulleux S. The medical treatment of radioiodine-refractory differentiated thyroid cancers in 2019. A TUTHYREF(R) network review. Bull Cancer. 2019 Sep;106(9):812-819. doi: 10.1016/j.bulcan.2019.04.012. Epub 2019 Jun 11. — View Citation

Durante C, Haddy N, Baudin E, Leboulleux S, Hartl D, Travagli JP, Caillou B, Ricard M, Lumbroso JD, De Vathaire F, Schlumberger M. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 2006 Aug;91(8):2892-9. doi: 10.1210/jc.2005-2838. Epub 2006 May 9. — View Citation

Fugazzola L, Elisei R, Fuhrer D, Jarzab B, Leboulleux S, Newbold K, Smit J. 2019 European Thyroid Association Guidelines for the Treatment and Follow-Up of Advanced Radioiodine-Refractory Thyroid Cancer. Eur Thyroid J. 2019 Oct;8(5):227-245. doi: 10.1159/000502229. Epub 2019 Aug 28. — View Citation

Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. — View Citation

Ibrahimpasic T, Ghossein R, Shah JP, Ganly I. Poorly Differentiated Carcinoma of the Thyroid Gland: Current Status and Future Prospects. Thyroid. 2019 Mar;29(3):311-321. doi: 10.1089/thy.2018.0509. — View Citation

Keutgen XM, Sadowski SM, Kebebew E. Management of anaplastic thyroid cancer. Gland Surg. 2015 Feb;4(1):44-51. doi: 10.3978/j.issn.2227-684X.2014.12.02. — View Citation

Lazar V, Bidart JM, Caillou B, Mahe C, Lacroix L, Filetti S, Schlumberger M. Expression of the Na+/I- symporter gene in human thyroid tumors: a comparison study with other thyroid-specific genes. J Clin Endocrinol Metab. 1999 Sep;84(9):3228-34. doi: 10.1210/jcem.84.9.5996. — View Citation

Nixon IJ, Whitcher MM, Palmer FL, Tuttle RM, Shaha AR, Shah JP, Patel SG, Ganly I. The impact of distant metastases at presentation on prognosis in patients with differentiated carcinoma of the thyroid gland. Thyroid. 2012 Sep;22(9):884-9. doi: 10.1089/thy.2011.0535. Epub 2012 Jul 24. — View Citation

Schlumberger M, Tahara M, Wirth LJ. Lenvatinib in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 May 7;372(19):1868. doi: 10.1056/NEJMc1503150. No abstract available. — View Citation

Zerdoud S, Giraudet AL, Leboulleux S, Leenhardt L, Bardet S, Clerc J, Toubert ME, Al Ghuzlan A, Lamy PJ, Bournaud C, Keller I, Sebag F, Garrel R, Mirallie E, Groussin L, Hindie E, Taieb D. Radioactive iodine therapy, molecular imaging and serum biomarkers for differentiated thyroid cancer: 2017 guidelines of the French Societies of Nuclear Medicine, Endocrinology, Pathology, Biology, Endocrine Surgery and Head and Neck Surgery. Ann Endocrinol (Paris). 2017 Jul;78(3):162-175. doi: 10.1016/j.ando.2017.04.023. Epub 2017 Jun 1. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of dendrogenin A (DDA) and 6-oxo-cholestane-3ß,5a-diol (OCDO) in thyroid tissue (healthy or malignant)	The measurement expressed in ng / g of thyroid tissue	12 months after the beginning of the study
Secondary	Presence of enzymes involved in dendrogenin A (DDA) and 6-oxo-cholestane-3ß,5a-diol (OCDO) production	intensity of signal in Liquid Chromatography-Mass Spectrometry	12 months after the beginning of the study
Secondary	Number of enzymes involved in denrognenin A (DDA) and 6-oxo-cholestane-3ß,5a-diol (OCDO) production	Quantify by immunohistochemistry	12 months after the beginning of the study