Cholesterol Metabolites Analysis in Human Thyroid and Iodine Resistance

NCT04821336 | Completed

• 1 other identifier: 21HLVADS01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer

Keywords

cholesterol metabolites; dendrogenin A (DDA); 6-oxo-cholestane-3β,5α-diol (OCDO); 5,6 epoxy cholesterol; thyroid cancer

Outcome Measures

Primary Outcomes (1)

• Rate of dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-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 Outcomes (2)

• Presence of enzymes involved in dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-diol (OCDO) production

  12 months after the beginning of the study

• Number of enzymes involved in denrognenin A (DDA) and 6-oxo-cholestane-3β,5α-diol (OCDO) production

  12 months after the beginning of the study

Study Arms (1)

Thyroid tissue samples

from 30 patients, tissue samples , frozen and embedded paraffin have been collected and preserved for research. For this study, tumoral tissue and healthy tissue will be used;

Other: Metabolites dosage

Interventions

Metabolites dosage OTHER

On samples investigators will quantify cholesterol metabolite and dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-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.

Thyroid tissue samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Cancer Research Center of Toulouse: collaborator

Study Sites (1)

Institut Claudius regaud IUCT Oncopole

Toulouse, 31059, France

Location

Related Publications (10)

• 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.

  PMID: 26462967 BACKGROUND

• 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.

  PMID: 28578852 BACKGROUND

• 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.

  PMID: 22827579 BACKGROUND

• 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.

  PMID: 31200896 BACKGROUND

• 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.

  PMID: 25946295 BACKGROUND

• 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.

  PMID: 31768334 BACKGROUND

• 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.

  PMID: 16684830 BACKGROUND

• 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.

  PMID: 25713779 BACKGROUND

• 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.

  PMID: 30747050 BACKGROUND

• 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.

  PMID: 10487692 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

frozen human thyroid samples (benign or malignant) paraffin embedded human thyroid tissue collection

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 15, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 1, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)