Thyroid CancerNCT01153945
Association Between Cancer Cells and Normal Versus (Vs.) Low Levels of Thyroid Hormones in the Serum
An observational study of Thyroid Cancer, run by Meir Medical Center at 1 site in Israel.
Trial summary
Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3, commonly over-expressed on many cancer cells. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jul 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thyroid cancer patients before/after radioactive iodine total body scan or treatment admitted to the Endocrinology Institute, Meir Medical Center
Who may be able to join
- Hypothyroid state
Who cannot join
- Non hypothyroid state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Cancer Cells and Normal Vs. Low Levels of Thyroid Hormones in the Serum
Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3, commonly over-expressed on many cancer cells. In the experimental settings, mimicking hypothyroidism in the cells is a difficult task. Currently, the use of charcoal stripped serum is used. Using this method, the serum is stripped not only from T3 and T4, as intended, but also from central and important cytokines and growth factor. This leads to a reduced rate of cancer cell proliferation and thus, does not reflect the natural environment in which cancer cells residue under hypothyroid conditions.
The investigators aim to characterize and establish the effects of serum from hypothyroid patients on the proliferation/viability of a variety of cancer cell models.
- Conditions
- Thyroid Cancer
- Keywords
- Hypothyroid and non hypothyroid
- Medical subject headings
- Thyroid Neoplasms, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroid | Not described | |
| Non hypothyroid | Not described | |
| Healthy subjects | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: The sponsor stopped the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Nabriski, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153945
- Sponsor's protocol ID
- 097-2010
- Status last verified
- Aug 2011
- First submitted
- 29 Jun 2010
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cancer Cells and Normal Vs. Low Levels of Thyroid Hormones in the Serum
- ClinicalTrials.gov ID
- NCT01153945
- Acronym / sponsor ID
- 097-2010
- Conditions
- Thyroid Cancer
- Keywords
- Hypothyroid and non hypothyroid
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor stopped the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Jun 2010 (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.
Much experimental data has suggested that thyroid hormones (T3 and T4) may modulate neoplastic cells and that T3/T4 deprivation may remove this stimulus. It is now well established that T3/T4 affects cell division/angiogenesis through binding to integrin avb3, commonly over-expressed on many cancer cells. In the experimental settings, mimicking hypothyroidism in the cells is a difficult task. Currently, the use of charcoal stripped serum is used. Using this method, the serum is stripped not only from T3 and T4, as intended, but also from central and important cytokines and growth factor. This leads to a reduced rate of cancer cell proliferation and thus, does not reflect the natural environment in which cancer cells residue under hypothyroid conditions.
The investigators aim to characterize and establish the effects of serum from hypothyroid patients on the proliferation/viability of a variety of cancer cell models.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypothyroid | – | – |
| Non hypothyroid | – | – |
| Healthy subjects | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thyroid cancer patients before/after radioactive iodine total body scan or treatment admitted to the Endocrinology Institute, Meir Medical Center
Key inclusion criteria (1 listed)
- Hypothyroid state
Key exclusion criteria (1 listed)
- Non hypothyroid state
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Dan Nabriski, MD principal investigator
Meir Medical Center
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 Thyroid Cancer, run by Meir Medical Center at 1 site in Israel.
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: withdrawn, as of the sponsor's last update on 7 Apr 2015. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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 7 Apr 2015.