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Thyroid Nodule Gene Sequencing in a Danish Population

Primary Purpose

Thyroid Nodule (Diagnosis), Thyroid Cancer

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Molecular analyses

About this trial

This is an interventional diagnostic trial for Thyroid Nodule (Diagnosis)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Thyroid nodule >1.5 cm
BSRTC: IV, V, og VI

Exclusion Criteria:

No surgical specimen available
Purely cystic nodules

Sites / Locations

Aarhus Universityhospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Molecular testing

Arm Description

Descriptive and explorative study including identical molecular analyses applied to all included patients

Outcomes

Primary Outcome Measures

DNA alterations

Whole genome sequencing by next generation sequencing

RNA alterations

Total RNA sequencing including circular RNA, micro RNA and messenger RNA

DNA methylation

Whole Genome Bisulfite Sequencing

Circulating tumor DNA

Whole genome sequencing of leucocyt DNA and circularing DNA

Secondary Outcome Measures

Full Information

NCT ID

NCT05377736

First Posted

March 15, 2022

Last Updated

June 11, 2023

Sponsor

Aarhus University Hospital

Collaborators

University of Aarhus, Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05377736

Brief Title

Thyroid Nodule Gene Sequencing in a Danish Population

Official Title

Thyroid Nodule Gene Sequencing in a Danish Population - A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

January 18, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital

Collaborators

University of Aarhus, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population. Patients with thyroid nodules suspected of malignancy is included prospectively. Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Nodule (Diagnosis), Thyroid Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Molecular testing

Arm Type

Experimental

Arm Description

Descriptive and explorative study including identical molecular analyses applied to all included patients

Intervention Type

Genetic

Intervention Name(s)

Molecular analyses

Intervention Description

Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery

Primary Outcome Measure Information:

Title

DNA alterations

Description

Whole genome sequencing by next generation sequencing

Time Frame

Two years

Title

RNA alterations

Description

Total RNA sequencing including circular RNA, micro RNA and messenger RNA

Time Frame

Two years

Title

DNA methylation

Description

Whole Genome Bisulfite Sequencing

Time Frame

Two years

Title

Circulating tumor DNA

Description

Whole genome sequencing of leucocyt DNA and circularing DNA

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Thyroid nodule >1.5 cm BSRTC: IV, V, og VI Exclusion Criteria: No surgical specimen available Purely cystic nodules

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristine Z Swan

Organizational Affiliation

Aarhus Universitetshospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus Universityhospital

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will be in accordance with Danish legislation and regulations within the area

Learn more about this trial

Thyroid Nodule Gene Sequencing in a Danish Population

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