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Influence of Thyroid Hormones on the Woundhealing Process

NCT ID: NCT00929318

Last Updated: 2009-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Neoplasms Thyroid Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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benign

patients after surgery because of a benign disease

Group Type ACTIVE_COMPARATOR

blood sampling

Intervention Type PROCEDURE

blood sampling

Intervention Type PROCEDURE

DTC

Patients after thyroidectomy because of papillary carcinoma of the thyroid gland

Group Type ACTIVE_COMPARATOR

blood sampling

Intervention Type PROCEDURE

Interventions

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blood sampling

Intervention Type PROCEDURE

blood sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Medizinische Hochschule Hannover

Locations

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Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stephan S Kaaden, Dr

Role: CONTACT

Phone: 0049-511-532 6131

Email: [email protected]

Georg FW Scheumann, Prof

Role: CONTACT

Phone: 0049-511-532 2032

Email: [email protected]

Facility Contacts

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Stephan Kaaden, Dr

Role: primary

Other Identifiers

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MHH-THY-WH-09

Identifier Type: -

Identifier Source: org_study_id