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Association Between Cancer Cells and Normal Versus (Vs.) Low Levels of Thyroid Hormones in the Serum

Primary Purpose

Thyroid Cancer

Status
Withdrawn
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Thyroid Cancer focused on measuring Hypothyroid and non hypothyroid

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hypothyroid state

Exclusion Criteria:

  • Non hypothyroid state

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

Hypothyroid

Non hypothyroid

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
April 6, 2015
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01153945
Brief Title
Association Between Cancer Cells and Normal Versus (Vs.) Low Levels of Thyroid Hormones in the Serum
Official Title
Association Between Cancer Cells and Normal Vs. Low Levels of Thyroid Hormones in the Serum
Study Type
Observational

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor stopped the study.
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Hypothyroid and non hypothyroid

7. Study Design

Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypothyroid
Arm Title
Non hypothyroid
Arm Title
Healthy subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypothyroid state Exclusion Criteria: Non hypothyroid state
Study Population Description
Thyroid cancer patients before/after radioactive iodine total body scan or treatment admitted to the Endocrinology Institute, Meir Medical Center
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nabriski, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Association Between Cancer Cells and Normal Versus (Vs.) Low Levels of Thyroid Hormones in the Serum

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