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Thyroid CancerOXYTHYRNCT04821336

Cholesterol Metabolites Analysis in Human Thyroid and Iodine Resistance

An observational study of Thyroid Cancer, run by Institut Claudius Regaud at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Metabolites dosage
How many people
30 participants
Where
1 siteFrance
Study dates
15 Apr 2021to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Claudius regaud IUCT Oncopole

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the detailed 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.

Conditions
Thyroid Cancer
Being tested
Metabolites dosage
Keywords
cholesterol metabolites, dendrogenin A (DDA), 6-oxo-cholestane-3β,5α-diol (OCDO), 5,6 epoxy cholesterol, thyroid cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolites dosageOther

    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.

Study groups in NCT04821336
Study groupRoleWhat they receive
Thyroid tissue samplesfrom 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;
Receives: Other: Metabolites dosage

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after the beginning of the study

Secondary outcomes (2)

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

    intensity of signal in Liquid Chromatography-Mass Spectrometry

    Measured: 12 months after the beginning of the study

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

    Quantify by immunohistochemistry

    Measured: 12 months after the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start15 Apr 2021
  3. Primary completion30 Sep 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821336
Sponsor's protocol ID
21HLVADS01
Acronym
OXYTHYR
Status last verified
Dec 2022
First submitted
25 Mar 2021
Last updated
1 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26462967

  • 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.

    PubMed 28578852

  • 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.

    PubMed 22827579

  • 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.

    PubMed 31200896

  • 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.

    PubMed 25946295

  • 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.

    PubMed 31768334

  • 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.

    PubMed 16684830

  • 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.

    PubMed 25713779

  • 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.

    PubMed 30747050

  • 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.

    PubMed 10487692

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer, run by Institut Claudius Regaud at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-diol (OCDO) in thyroid tissue (healthy or malignant) (time frame: 12 months after the beginning of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821336, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.

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