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Study of Molecular Pathways in Medullary Thyroid Carcinoma (MTC) and Correlation of Molecular Data With Clinical Behavior of the MTC in Individuals Patients


N/A
2 Years
80 Years
Not Enrolling
Both
Medullary Thyroid Carcinoma, Multiple Endocrine Neoplasia Type 2

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Trial Information

Study of Molecular Pathways in Medullary Thyroid Carcinoma (MTC) and Correlation of Molecular Data With Clinical Behavior of the MTC in Individuals Patients


Background:

Medullary thyroid carcinoma (MTC) is a rare malignancy, occurring either as a sporadic
disease (75% of cases), or in a hereditary pattern as multiple endocrine neoplasia (MEN)
type 2 (MEN2A or MEN2B) or familial medullary thyroid carcinoma (FMTC). The MTC arises from
the neural crest C-cells and in hereditary cases the first pathological disorder is C-cell
hyperplasia (CCH) Most patients with MTC have advanced disease at the time of diagnosis.

Chemotherapy and external beam radiotherapy have been minimally effective. Molecular
targeted therapeutics (MTTs) and other receptor kinases in patients with advanced MTC have
demonstrated activity.

Despite some clinical responses, the collection of tumor tissues and autologous normal
tissues has been virtually non-existent. Thus, laboratory studies defining affected
molecular targets and downstream pathways, and molecular data providing direction for future
clinical trials has yet to occur.

Data from molecular studies of tumor tissue of hereditary or sporadic MTC patients will
assist in predicting clinical behavior and the biology of MTC in predicting response to a
given MTT, and in designing combination clinical trials.

Objectives:

Clarify how normal molecular pathways are altered by mutations in the RET protooncogene.
Including additional genetic mutations and unidentified chromosomal translocations.

Correlate results from molecular analyses of MTC tissue with patient's clinical course.

Define how the molecular and clinical data will be useful in designing targeted therapy for
patients with MTC.

Eligibility:

Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic MTC
with archived pathology specimens available at Washington University.

Design:

Paraffin blocks of MTC tissues from archival samples at Washington University Department of
Pathology will be selected.

H& E slide from selected tissue blocks will be examined for molecular study suitability.

Necessary tissue samples from blocks will have molecular studies, including, gene arrays,
array comparative genomic hybridization, immunohistochemistry, and sequencing.

Retrospective chart review will occur to obtain relevant clinical information.

Inclusion Criteria


- INCLUSION CRITERIA:

Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic
MTC with archived pathology specimens available at Washington University.

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Principal Investigator

Antonio T Fojo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999910167

NCT ID:

NCT01424878

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Medullary Thyroid Carcinoma
  • Multiple Endocrine Neoplasia Type 2
  • Molecular Analysis of Medullary Thyroid Carcinoma Tissues
  • Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Endocrine Gland Neoplasms
  • Multiple Endocrine Neoplasia Type 2a
  • Multiple Endocrine Neoplasia
  • Thyroid Diseases

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892