OXYTHYR: Cholesterol Metabolites Analysis in Human Thyroid and Iodine Resistance

Sponsor
Institut Claudius Regaud (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04821336
Collaborator
Cancer Research Center of Toulouse (Other)
30
1
12.9
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Metabolites dosage

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Rate of dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-diol (OCDO) in thyroid tissue (healthy or malignant) [12 months after the beginning of the study]

    The measurement expressed in ng / g of thyroid tissue

Secondary Outcome Measures

  1. 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]

    intensity of signal in Liquid Chromatography-Mass Spectrometry

  2. 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]

    Quantify by immunohistochemistry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Claudius regaud IUCT Oncopole Toulouse France 31059

Sponsors and Collaborators

  • Institut Claudius Regaud
  • Cancer Research Center of Toulouse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT04821336
Other Study ID Numbers:
  • 21HLVADS01
First Posted:
Mar 29, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Claudius Regaud
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021