Health TrialsbyHealthPanel

Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

ConditionThyroid Gland Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis

Over the age of 18

Any gender, race and ethnicity

Patients must provide informed consent prior to use of their tissues and clinical data

Disqualifiers

Children are excluded from the study, since the biology of children thyroid nodules is different from adults

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic Procedure

    Procedure/Surgery

    Analysis via DDMS-2

  • Electronic Health Record Review

    Other intervention

    Review of medical records

  • Needle Biopsy

    Procedure/Surgery

    Undergo needle biopsy

Treatment groups

1,450 Participants
are divided into 1 treatment group
Group A: Diagnostic (needle biopsy, DDMS-2)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)

The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals.

Time frame
Up to 5 years
2

Specificity of DDMS-2

The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals.

Time frame
Up to 5 years
3

Positive predictive value (PPV) of DDMS-2

PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

Time frame
Up to 5 years
4

Negative predictive value (NPV) of DDMS-2

NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now