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Influence of Thyroid Hormones on the Woundhealing Process

Primary Purpose

Thyroid Neoplasms, Thyroid Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

blood sampling

About this trial

This is an interventional basic science trial for Thyroid Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

benign

DTC

Arm Description

patients after surgery because of a benign disease

Patients after thyroidectomy because of papillary carcinoma of the thyroid gland

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00929318

First Posted

June 26, 2009

Last Updated

June 26, 2009

Sponsor

Hannover Medical School

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00929318

Brief Title

Influence of Thyroid Hormones on the Woundhealing Process

Official Title

Clinical Investigations on Cytokin-Gradients in Hypo/Euthyroid Patients. Evaluation of Expression of Different Pro-and Anti-Inflammatory Cyto-/Chemokines in Skin Wounds After Surgery of Benign Goitres (Struma Multinodosa) or Malignant Diseases of Thyroid Gland (Papillary Thyroid Carcinoma) in Correlation to the Status of Wound Healing of the Neck Wound

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hannover Medical School

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Neoplasms, Thyroid Carcinoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

benign

Arm Type

Active Comparator

Arm Description

patients after surgery because of a benign disease

Arm Title

DTC

Arm Type

Active Comparator

Arm Description

Patients after thyroidectomy because of papillary carcinoma of the thyroid gland

Intervention Type

Procedure

Intervention Name(s)

blood sampling

Intervention Type

Procedure

Intervention Name(s)

blood sampling

Primary Outcome Measure Information:

Title

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

Time Frame

21 days after surgery

Secondary Outcome Measure Information:

Title

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

Time Frame

21 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephan S Kaaden, Dr

Phone

0049-511-532 6131

Kaaden.Stephan@mh-hannover.de

First Name & Middle Initial & Last Name or Official Title & Degree

Georg FW Scheumann, Prof

Phone

0049-511-532 2032

scheumann.georg@mh-hannover.de

Facility Information:

Facility Name

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

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Kaaden, Dr

First Name & Middle Initial & Last Name & Degree

Stephan Kaaden, Dr

12. IPD Sharing Statement

Learn more about this trial

Influence of Thyroid Hormones on the Woundhealing Process

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