Influence of Thyroid Hormones on the Woundhealing Process

NCT00929318 | Unknown

• 1 other identifier: MHH-THY-WH-09
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Neoplasms; Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples

  21 days after surgery

Secondary Outcomes (1)

• Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.

  21 days after surgery

Study Arms (2)

benign

ACTIVE COMPARATOR

patients after surgery because of a benign disease

Procedure: blood sampling

DTC

ACTIVE COMPARATOR

Patients after thyroidectomy because of papillary carcinoma of the thyroid gland

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

DTC; benign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

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

Hanover, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Stephan S Kaaden, Dr

CONTACT

0049-511-532 6131; Kaaden.Stephan@mh-hannover.de

Georg FW Scheumann, Prof

CONTACT

0049-511-532 2032; scheumann.georg@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 29, 2009

Record last verified: 2009-06

Locations

DE (1)