TumorsNCT00459498
Expression of NIS Protein and mRNA in Thyroid Tumors
An observational study of Tumors, run by University of Sao Paulo.
Trial summary
The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumors
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Oct 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAtients with thyroid tumors undergoing surgery for total or partial thyroidectomy
Who cannot join
- Pregnancy
About this study
Official title: Significant Intracellular NIS Protein Associated With Low Levels of NIS Messenger RNA in Malignant Thyroid Tumors
The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.
Read the detailed description
The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR
- Conditions
- Tumors
- Keywords
- NIS, thyroid adenoma, thyroid cancer, Iodine uptake, expression
- Medical subject headings
- Neoplasms, Thyroid Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2002
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Ana K Sodré, Principal investigator, University of Sao PauloRosalinda Y Camargo, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459498
- Sponsor's protocol ID
- PRN736/02
- Status last verified
- Apr 2007
- First submitted
- 10 Apr 2007
- Last updated
- 12 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Saito T, Endo T, Kawaguchi A, Ikeda M, Katoh R, Kawaoi A, Muramatsu A, Onaya T. Increased expression of the sodium/iodide symporter in papillary thyroid carcinomas. J Clin Invest. 1998 Apr 1;101(7):1296-300. doi: 10.1172/JCI1259.
PubMed 9525971
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significant Intracellular NIS Protein Associated With Low Levels of NIS Messenger RNA in Malignant Thyroid Tumors
- ClinicalTrials.gov ID
- NCT00459498
- Acronym / sponsor ID
- PRN736/02
- Conditions
- Tumors
- Keywords
- NIS, thyroid adenoma, thyroid cancer, Iodine uptake, expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.
Detailed description
The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PAtients with thyroid tumors undergoing surgery for total or partial thyroidectomy
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2007.
- Background: PubMed 9525971Saito T, Endo T, Kawaguchi A, Ikeda M, Katoh R, Kawaoi A, Muramatsu A, Onaya T. Increased expression of the sodium/iodide symporter in papillary thyroid carcinomas. J Clin Invest. 1998 Apr 1;101(7):1296-300. doi: 10.1172/JCI1259.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana K Sodré principal investigator
University of Sao Paulo
Rosalinda Y Camargo study director
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2007.