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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02879968
Other study ID # PrinceSongklaU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date August 2018

Study information

Verified date March 2020
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.


Description:

The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.

The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).

The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.

Correlation between both parameters will be determined.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically proven squamous cell carcinoma in Head and Neck

- Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen

Exclusion Criteria:

- Metastatic disease

- Accompanied Non-Head and Neck squamous cell carcinoma

- Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma

- Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis

- Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst

- Renal failure

- Using antihistamine eye drops

Study Design


Intervention

Other:
Non-interventional study


Locations

Country Name City State
Thailand Faculty of Medicine, Prince of Songkla University Hadyai Songkhla

Sponsors (1)

Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between serum squamous cell carcinoma antigen and tumor volume 2 weeks
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