Study of Molecular Pathways in Medullary Thyroid Carcinoma and Correlation of Molecular Data With Clinical Behavior of the MTC in Individuals Patients
2 other identifiers
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2010
Typical duration for all trials
1 active site
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 Start
First participant enrolled
July 5, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2014
CompletedApril 5, 2018
February 12, 2014
August 26, 2011
April 4, 2018
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic MTC with archived pathology specimens available at Washington University.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio T Fojo, M.D.
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 26, 2011
First Posted
August 29, 2011
Study Start
July 5, 2010
Study Completion
February 12, 2014
Last Updated
April 5, 2018
Record last verified: 2014-02-12