NCT05428371

Brief Summary

Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

June 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

4.4 years

First QC Date

June 16, 2022

Last Update Submit

June 16, 2022

Conditions

Thyroid NoduleThyroid Cancer

Keywords

Thyroid carcinomaIndeterminate thyroid noduleGenomicsProteomicsMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Identification of biomarkers of thyroid carcinoma

    Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma

    50 months

Secondary Outcomes (1)

  • Elaboration of diagnostic algorithm

    60 months

Study Arms (2)

Thyroid carcinoma

Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma

Diagnostic Test: Multiomic analyses of blood and surgical specimens

Follicular adenoma

Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma

Diagnostic Test: Multiomic analyses of blood and surgical specimens

Interventions

Multiomic analyses of blood and surgical specimensDIAGNOSTIC_TEST

The following items will be evaluated: * cell free dna length and integrity * presence or absence of SNPs in cfDNA and in DNA extracted from surgical samples * qualitative and quantitative evaluation of serum and surgical specimens proteome (proteomics)

Follicular adenomaThyroid carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)

You may qualify if:

  • Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)

You may not qualify if:

  • Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
  • Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
  • Patients with distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Cagliari

Cagliari, CA, 09100, Italy

Location

MeSH Terms

Conditions

Thyroid NoduleThyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 23, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations

IT(1)