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Trial Title:
Influence of Thyroid Hormones on the Woundhealing Process
NCT ID:
NCT00929318
Condition:
Thyroid Neoplasms
Thyroid Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
blood sampling
Arm group label:
DTC
Arm group label:
benign
Intervention type:
Procedure
Intervention name:
blood sampling
Arm group label:
benign
Summary:
Main goal of this clinical investigation is to investigate different cytokines in wound
fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate
if different cytokine levels in euthyroid vs. hypothyroid patients exist and to what
extent these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1.
From the literature these 4 factors seem to be the most reasonable to measure and to
focus on. Additionally we focus on these 4 factors for financial reasons, technically
there wouldn't be a problem to measure more, which is correlated with higher costs.
Besides, more than 6 factors would mean larger amounts of sample fluids needed, which
would cause technical problems. These factors don't have to change in the same direction.
Secondarily, we believe that differences in cytokine profiles of hypothyroidism vs.
euthyroidism will correlate to differences in duration and clinical characteristics of
the wound healing process.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with
or without substitution of thyroid hormone after operation
- Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2
carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH
Exclusion Criteria:
- Pat< 18 years
- Immune disease of thyroid gland (Graves disease)
- Severe immunodeficiency
- Immunosuppressive medication because of solid Organ transplantation
- Hepatitis A/B/C or HIV
- All exclusion criteria for any surgical procedure
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stephan Kaaden, Dr
Investigator:
Last name:
Stephan Kaaden, Dr
Email:
Sub-Investigator
Start date:
June 2009
Completion date:
April 2010
Lead sponsor:
Agency:
Hannover Medical School
Agency class:
Other
Collaborator:
Agency:
Genzyme, a Sanofi Company
Agency class:
Industry
Source:
Hannover Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00929318
