Breast CancerNCT00568438
Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival & Frozen Tissue Sample
An observational study of Breast Cancer and Stomach Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to study NIS expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Stomach Neoplasms, Salivary Gland Neoplasms
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to 31 Dec 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cases will be identified from clinic patient medical records and linked to pathology reports. The surgical pathology record number will thus be obtained and used to retrieve the archival blocks and slides. In addition, all these participants will be clinical patients of the Protocol Director, thus the Physician will always be familiar with the participants.
Who may be able to join
- Patient must be over the age of 18.
- Patients must have benign and malignant breast and thyroid cancer.
- Patient mus sign consent form.
Who cannot join
- 1. No children will be allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival and Frozen Human Tissue Samples
The goal of this study is to study NIS expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections.
Read the detailed description
The objective of the study is to further understanding of proteins that occur in both normal cells and tumor cells and to learn more about certain diseases and potential alternative treatments for these diseases.
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Salivary Gland 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 posted6 Dec 2007 (estimated)
- Study startOct 2000
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene L Wapnir, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568438
- Sponsor's protocol ID
- IRB-11005
- Other IDs
- BRSNSTU0011
- Status last verified
- Aug 2023
- First submitted
- 4 Dec 2007
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival and Frozen Human Tissue Samples
- ClinicalTrials.gov ID
- NCT00568438
- Acronym / sponsor ID
- IRB-11005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 6 Dec 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 goal of this study is to study NIS expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections.
Detailed description
The objective of the study is to further understanding of proteins that occur in both normal cells and tumor cells and to learn more about certain diseases and potential alternative treatments for these diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be identified from clinic patient medical records and linked to pathology reports. The surgical pathology record number will thus be obtained and used to retrieve the archival blocks and slides. In addition, all these participants will be clinical patients of the Protocol Director, thus the Physician will always be familiar with the participants.
Key inclusion criteria (3 listed)
- Patient must be over the age of 18.
- Patients must have benign and malignant breast and thyroid cancer.
- Patient mus sign consent form.
Key exclusion criteria (1 listed)
- 1. No children will be allowed.
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 3 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Irene L Wapnir, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Stomach Neoplasms, run by Stanford University at 1 site in United States.
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 3 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 3 Aug 2023.