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Percentage of BRAFV600E Alleles and Outcome in Thyroid Carcinoma

NCT04664413 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-12-14

No results posted yet for this study

Summary

BRAFV600E is the most frequent oncogene in Papillary thyroid carcinoma (PTC). It correlates with greater extension, lymph node metastasis, and advanced stage. However, the prognostic value of BRAFV600Eis weak and the search of this mutation is not recommended in clinical management of thyroid cancer.

PTC are characterized by intratumor heterogeneity with wild-type and BRAFV600E tumoral cells. In a previous study, the BRAFV600E/BRAFwild-type ratio correlated with patient age, tumor volume, lymph node metastasis and with worst disease outcome. While the existence of intratumor heterogeneity in PTC is supported by many evidences, its extension, biological significance and clinical utility is questioned and must be further investigated.

Primary endpoint of the study is to determine the relationship between the percentage of BRAFV600E alleles and outcome in PTC patients. Secondary endpoints are to determine the mean and median BRAFV600E/BRAFwild-type allele ratio in heterogeneous tumors; determine the relationship between the percentage of BRAFV600E alleles and clinicopathological features.

The study protocol entails the assessment by digital-droplet PCR the BRAFV600E/BRAFwild-type allele ratio in a series of PTC and its correlation with clinicopathology features and outcome.

Conditions

  • Papillary Thyroid Cancer

Sponsors & Collaborators

  • University of Salerno

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-04-30
Completion
2021-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664413 on ClinicalTrials.gov